Devices, Systems and Methods for Treating Disorders of the Ear, Nose and Throat

ABSTRACT

Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies. Access and occluding devices may be used to facilitate insertion of working devices such asendoscopes, wires, probes, needles, catheters, balloon catheters, dilation catheters, dilators, balloons, tissue cutting or remodeling devices, suction or irrigation devices, imaging devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting or delivering devices and implants, etc.

RELATED APPLICATION

This application is a continuation of copending U.S. patent applicationSer. No. 11/037,548 entitled “Devices, Systems and Methods for TreatingDisorders of the Ear, Nose and Throat” filed on Jan. 18, 2005 which is acontinuation-in-part of 1) U.S. patent application Ser. No. 10/829,917entitled “Devices, Systems and Methods for Diagnosing and TreatingSinusitis and Other Disorders of the Ears, Nose and/or Throat” filed onApr. 21, 2004, 2) U.S. patent application Ser. No. 10/912,578 entitled“Implantable Device and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders” filed on Aug. 4, 2004and 3) U.S. patent application Ser. No. 10/944,270 entitled “Apparatusand Methods for Dilating and Modifying Ostia of Paranasal Sinuses andOther Intranasal or Paranasal Structures” filed on Sep. 17, 2004, theentire disclosure of each such parent application being expresslyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods and more particularly to minimally invasive devices, systems andmethods for treating sinusitis and other ear, nose & throat disorders.

BACKGROUND OF THE INVENTION

Surgical treatments for sinusitis and other disorders of the ear, noseand throat have evolved slowly over the years. In current clinicalpractice, functional endoscopic sinus surgery (FESS) is often used totreat sinusitis or other disorders where drainage of mucous is impairedand/or chronic infections are present. In FESS, an endoscope is insertedinto the nose and, under visualization through the endoscope, thesurgeon may remove diseased or hypertrophic tissue or bone and mayenlarge the ostia of the sinuses to restore normal drainage of thesinuses. FESS procedures can be effective in the treatment of sinusitisand for the removal of tumors, polyps and other aberrant growths fromthe nose. Other endoscopic intranasal procedures have been used toremove pituitary tumors, to treat Graves disease (i.e., a complicationof hyperthyroidism which results in protrusion of the eyes) and surgicalrepair of rare conditions wherein cerebrospinal fluid leaks into thenose (i.e., cerebrospinal fluid rhinorrhea).

In some instances, sinus and ENT surgery has been performed with theassistance of electronic navigation devices (i.e., “image-guided FESS”).In such image guided surgical procedures, integrated anatomicalinformation is supplied through CT-scan images or other anatomicalmapping data taken before the operation. Data from a preoperative CTscan or other anatomical mapping procedure is downloaded into a computerand special sensors known as localizers are attached to the surgicalinstruments. Thus, using the computer, the surgeon can ascertain, inthree dimensions, the precise position of each localizer-equippedsurgical instrument at any given point in time. This information,coupled with the visual observations made through the standardendoscope, can help the surgeon to carefully position the surgicalinstruments to avoid creating CSF leaks and to avoid causing damage tonerves or other critical structures.

Although FESS continues to be the gold standard therapy for severesinuses, it has several shortfalls. Often patients complain of thepost-operative pain and bleeding associated with the procedure, and asignificant subset of patients remain symptomatic even after multiplesurgeries. Since FESS is considered an option only for the most severecases (those showing abnormalities under CT scan), a large population ofpatients exist that can neither tolerate the prescribed medications norbe considered candidates for surgery. Further, because the methodologiesto assess sinus disease are primarily static measurements (CT, MRI),patients whose symptoms are episodic are often simply offered drugtherapy when in fact underlying mechanical factors may play asignificant role. To date, there is no mechanical therapy offered forthese patients, and even though they may fail pharmaceutical therapies,no other course of action is indicated. This leaves a large populationof patients in need of relief, unwilling or afraid to take steroids, butnot sick enough to qualify for surgery.

Some experimental or investigational procedures have also been performedin an effort to treat sinusitis by methods that are less invasive and/orless damaging to ancillary tissues than FESS. For example, Europeanphysicians have reported the use of a hydrophilic guidewire and standardPTCA balloon catheter to treat restenosis of surgically created openingsin diseased frontal sinuses and stenotic nasal conae. Göttmann, D.,Strohm, M., Strecker, E. P., Karlsruhe, D. E., Balloon dilatation ofRecurrent Ostial Oclusion of the Frontal Sinus, Abstract No. B-0453,European Congress of Radiology (2001); Strohm, M., Göttmann, D.,Treatment of Stenoses of Upper Air Routes by Balloon Dilation,Proceeding of the 83^(rd) Annual Convention of the Association of WestGerman ENT Physicians (1999). The interventions described in thisabstract were conducted only on frontal sinuses that had previously beensurgically modified and nasal conae. These techniques were not reportedto be useable for the treatment of sinus ostia that has not previouslybeen surgically altered or ostia of sinuses other than the easilyaccessible frontal sinuses. Also, in these reported cases, standardvascular guidewires and angioplasty balloon catheters were used. Thetechniques described in these publications have not been widely adoptedby ENT surgeons, possibly due to the fact that they lacked importantnovel improvements and modifications as described in this patentapplication and prior U.S. patent application Ser. Nos. 10/829,917,10/912,578 and 10/944,270, of which this application is acontinuation-in-part.

Other methods and devices for sinus intervention using dilating balloonshave been disclosed in U.S. Pat. No. 2,525,183 (Robison) and UnitedStates Patent Publication No. 2004/0064150 A1 (Becker). For example,U.S. Pat. No. 2,525,183 (Robison) discloses an inflatable pressuredevice which can be inserted following sinus surgery and inflated withinthe sinus. The patent does not disclose device designs and methods forflexibly navigating through the complex nasal anatomy to access thenatural ostia of the sinuses. The discussion of balloon materials isalso fairly limited to thin flexible materials like rubber which aremost likely to be inadequate for dilating the bony ostia of the sinus.

United States patent publication number 2004/0064150 A1 (Becker)discloses balloon catheters formed of a stiff hypotube to be pushed intoa sinus. The balloon catheters have a stiff hypotube with a fixedpre-set angle that enables them to be pushed into the sinus. In at leastsome procedures wherein it is desired to position the balloon catheterin the ostium of a paranasal sinus, it is necessary to advance theballoon catheter through complicated or tortuous anatomy in order toproperly position the balloon catheter within the desired sinus ostium.Also, there is a degree of individual variation in the intranasal andparanasal anatomy of human beings, thus making it difficult to design astiff-shaft balloon catheter that is optimally shaped for use in allindividuals. Indeed, rigid catheters formed of hypotubes that havepre-set angles cannot be easily adjusted by the physician to differentshapes to account for individual variations in the anatomy. In view ofthis, the Becker patent application describes the necessity of havingavailable a set of balloon catheters, each having a particular fixedangle so that the physician can select the appropriate catheter for thepatient's anatomy. The requirement to test multiple disposable cathetersfor fit is likely to be very expensive and impractical. Moreover, ifsuch catheter are disposable items (e.g., not sterilizable and reusable)the need to test and discard a number of catheters before finding onethat has the ideal bend angle could be rather expensive.

The prior art has not provided catheters, devices, systems and methodsthat are optimal for minimally invasive treatment of sinusitis,mucocysts, tumors, infections, hearing disorders, fractures, choanalatresia or other conditions of the paranasal sinuses, Eustachian tubes,Lachrymal ducts and other ear, nose, throat or mouth structures.

SUMMARY OF THE INVENTION

In general, the present invention provides methods, devices and systemsfor diagnosing and/or treating sinusitis, mucocysts, tumors, infections,hearing disorders, fractures, choanal atresia or other conditions of theparanasal sinuses, Eustachian tubes, Lachrymal ducts, ducts of salivaryglands and other ear, nose, throat or mouth structures.

In accordance with the present invention, there are provided methodswherein one or more flexible catheters or other flexible elongatedevices as described herein are inserted in to the nose, nasopharynx,paranasal sinus, Eustachian tubes, middle ear, lachrymal ducts, ducts ofsalivary glands or other anatomical passageways of the ear, nose, throator mouth to perform an interventional or surgical procedure. Examples ofprocedures that may be performed using these flexible catheters or otherflexible elongate devices include but are not limited to; deliveringcontrast medium; performing an imaging study, delivering atherapeutically effective amount of a therapeutic substance; implantinga stent or a tissue remodeling device, substance delivery implant orother therapeutic apparatus; cutting, ablating, debulking, cauterizing,heating, dilating or otherwise modifying tissue such as nasal polyps,aberrant or enlarged tissue, abnormal tissue, etc.; grafting orimplanting cells or tissue; reducing, setting, affixing or otherwisetreating a fracture, delivering a gene or gene therapy preparation;cuffing, ablating, debulking, cauterizing, heating, freezing, lasing,forming an osteotomy or trephination in or otherwise modifying bony orcartilaginous tissue within paranasal sinus, nasopharynx, Eustachiantube, middle ear, Lachrymal duct or elsewhere within the ear, nose,throat or mouth; remodeling or changing the shape, size or configurationof a sinus ostium or other anatomical structure that affects drainagefrom one or more paranasal sinuses; removing puss or aberrant matterfrom the paranasal sinus or elsewhere within the nose; scraping orotherwise removing cells that line the interior of a paranasal sinus;removing all or a portion of a tumor; removing a polyp; deliveringhistamine, an allergen or another substance that causes secretion ofmucous by tissues within a paranasal sinus to permit assessment ofdrainage from the sinus etc.

Still further in accordance with the invention, there are provided novelaccess, stabilizing and occluding devices. They may be used tofacilitate insertion of working devices such as endoscopes, guidewires,catheters (e.g. balloon catheters), tissue cutting or remodelingdevices, sizing devices, biopsy devices, image-guided devices containingsensors or transmitters, electrosurgical devices, energy emittingdevices, devices for injecting diagnostic or therapeutic agents, devicesfor implanting devices such as stents, substance eluting devices,substance delivery implants, etc. into the paranasal sinuses and otherstructures in the ear, nose, throat or mouth for performing some or allof the procedures described herein.

Still further in accordance with the invention, there are presentedseveral modalities for navigation and imaging of the interventionaldevices within the nose, nasopharynx, paranasal sinuses, Eustachiantubes, middle ear, lachrymal ducts, ducts of salivary glands or otheranatomical passageways of the ear, nose, throat or mouth usingendoscopic, fluoroscopic, radiofrequency localization, electromagneticand other radioactive energy based imaging and navigation modalities.These imaging and navigation technologies may also be referenced bycomputer directly or indirectly to pre-existing or simultaneouslycreated 3-D or 2-D data sets which help the doctor place the deviceswithin the appropriate region of the anatomy.

Still further in accordance with the invention, there are providedmethods for improving drainage from a paranasal sinus that has a naturalostium that has not previously been surgically altered, said methodcomprising the steps of: A) providing an elongate guide (e.g., a wire,rod, probe, guidewire, flexible member, malleable member, tube, cannula,catheter, stylets, etc.) and a dilator (e.g., a dilation catheter,balloon catheter, expandable member, etc.); B) advancing the elongateguide to a position within or near the ostium; C) using the elongateguide to advance the dilator to a position where the dilator is withinthe ostium; and D) using the dilator to dilate the natural ostium. Thedilation of the natural ostium may, in at least some cases, result inbreaking or rearrangement of bone that underlies the mucosa of theostium.

Still further in accordance with the invention, there is provided amethod for treating a mucocyst or other or otherflowable-substance-containing structure located within a paranasalsinus, said method comprising the steps of A) providing a penetratorthat is useable to form an opening in the mucocyst or otherflowable-substance-containing structure; B) providing a compressoruseable to compress the mucocyst or other flowable-substance-containingstructure after an opening has been formed therein by the penetratorsuch that its contents will be forced out of the opening formed by thepenetrator; C) advancing the penetrator into the paranasal sinus andusing the penetrator to form an opening in the mucocyst or otherflowable-substance-containing structure, and D) positioning thecompressor in the paranasal sinus and using the compressor to compressthe mucocyst or other flowable-substance-containing structure such thatits contents will be forced out of the opening formed by the penetrator.

Still further in accordance with the invention, there is provided amethod for dilating a Eustachian tube in a human or animal subject, saidmethod comprising the steps of: A) providing a guide member (e.g., aguidewire) that is insertable through the nose and is advanceable intothe Eustachian tube through the pharyngeal ostium of the Eustachian tubeand a dilator that is advanceable over the guidewire and useable todilate the Eustachian tube; B) inserting the guidewire into theEustachian tube; C) advancing the dilator over the guide member and intothe Eustachian tube; and D) using the dilator to dilate the Eustachiantube. In some embodiments of this method, the guide member (e.g.,guidewire) may have an anchor (e.g., a balloon) for holding the guidemember in a substantially fixed position within the Eustachian tube,thereby guarding against inadvertent advancement of the guide member ordilation catheter into the middle ear as may injure the bones of themiddle ear. In some embodiments, marker(s) such as radiopaque markersmay be provided on the guide member and/or may be inserted into theadjacent ear canal next to the tympanic membrane to allow the operatorto clearly view the location at which the Eustachian tube enters themiddle ear, thereby further guarding against inadvertent advancement ofthe device(s) into the middle ear.

Still further in accordance with the invention, there is provided amethod for modifying a bony structure within the nose or paranasal sinushuman or animal subject, said method comprising the steps of: A)providing a direct viewing apparatus (e.g., a scope, rigid scope,flexible scope, camera, video camera, intranasal camera similar to anintraoral camera but sized for insertion into the nares or nasalcavity), B) inserting the direct viewing apparatus into the nose; C)advancing a guide device to a first location within the nasal cavity orparanasal sinus under direct viewing using the direct viewing apparatus;D) providing an indirect viewing apparatus (e.g., an imaging device,fluoroscope, fluoroscope with C-arm, magnetic resonance imaging device,tomographic device, CT scanner, electromagnetic navigational and/orguidance system, PET scanner, combination CT/PET scanner and opticalcoherence tomography device, etc.); E) advancing a working device (e.g.,an endoscope, wire, probe, needle, catheter, balloon catheter, dilationcatheter, dilator, balloon, tissue cutting or remodeling device, suctionor irrigation device, imaging device, sizing device, biopsy device,image-guided device containing sensor or transmitter, electrosurgicaldevice, energy emitting device such as laser, rf, etc., device forinjecting diagnostic or therapeutic agent, device for implanting otherarticles such as stents, substance eluting or delivering device,implant, etc.) over the guide device to a second location within thenasal cavity or paranasal sinus, under indirect viewing using the directviewing apparatus; and F) using the working device to perform atherapeutic or diagnostic procedure.

Still further in accordance with the invention, there is provided amethod for determining the position of a device within the body of ahuman or animal subject, said method comprising the steps of A)providing a device having an electromagnetic element (e.g., a sensor orelectromagnetic coil) thereon; B) providing a plurality of fiducialmarkers which emit electromagnetic energy and an attachment substance orapparatus for removably attaching the fiducial markers to teeth, bonesor other anatomical structures; C) using the attachment substance orapparatus to removably attach the fiducial markers to teeth, bones orother anatomical structures of the subject's body; D) performing animaging procedure to obtain an image of a portion of the subject's bodyincluding the fiducial markers; and, thereafter, E) advancing the deviceinto the subject's body and detecting the electromagnetic element on thedevice as well as the electromagnetic energy emitted by the fiducialmarkers; and F) using the image obtained in Step D and the informationdetected in Step E to determine the current position of the devicewithin the subject's body.

Further aspects, details and embodiments of the present invention willbe understood by those of skill in the art upon reading the followingdetailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic diagram of the general working environment ofan example of a system for catheter-based minimally invasive sinussurgery being used to perform a sinus surgery on a human patient.

FIG. 1A shows a magnified view of region 1A of FIG. 1 showing a systemfor catheter-based minimally invasive sinus surgery of a human patient.

FIG. 1B shows a perspective view of a treatment tray for catheter-basedminimally invasive sinus surgery of a human patient.

FIG. 2A shows a portion of a stabilizing device comprising a stabilizingmember.

FIGS. 2B-2D show various alternate embodiments of stabilizing member ofFIG. 2A.

FIG. 2E-2G show perspective views of various embodiments of inflatableoccluding devices.

FIGS. 3A-3D′ show embodiments of stabilizing members comprising anadhesive element.

FIGS. 4A and 4B show perspective views of an occluding device indeflated and inflated states respectively.

FIG. 5 shows a perspective view of a guide catheter comprising aplastically deformable (malleable) region.

FIG. 6 shows a perspective view of a guide catheter comprising alubricious layer.

FIG. 6A shows a crossectional view of the guide catheter of FIG. 6through the plane 6A-6A.

FIG. 7 shows perspective view of an embodiment of a guide cathetercomprising a straight hypotube.

FIG. 7A shows a crossection of the guide catheter of FIG. 7 throughplane 7A-7A.

FIG. 8 shows perspective view of a second embodiment of a guide cathetercomprising a straight hypotube.

FIG. 8A shows a crossection of the guide catheter of FIG. 8 throughplane 8A-8A.

FIG. 8B shows a crossection of the guide catheter of FIG. 8 throughplane 8B-8B.

FIG. 8C shows a perspective view of an embodiment of a guide cathetercomprising a curved or bent hypotube to facilitate access to the frontalsinuses.

FIG. 8D shows a perspective view of a second embodiment of a guidecatheter comprising a curved or bent hypotube to facilitate access tothe sphenoid sinuses.

FIG. 8E shows a perspective view of an embodiment of a guide cathetercomprising two bent or angled or curved regions to facilitate access tothe maxillary sinuses.

FIG. 8F shows a perspective view of a second embodiment of a guidecatheter comprising two bent or angled or curved regions and a hypotubeto facilitate access to the maxillary sinuses.

FIG. 8G shows a coronal section of the paranasal anatomy showing amethod of accessing a maxillary sinus ostium using the guide catheter ofFIG. 8F.

FIG. 8H shows a sagittal section of the paranasal anatomy showing themethod of FIG. 8G to access a maxillary sinus ostium using the guidecatheter of FIG. 8F.

FIG. 8I shows a perspective view of an example of a guide cathetercomprising a common proximal portion and a plurality of detachabledistal tips.

FIG. 9 shows a perspective view of a set of devices to dilate or modifyostia or other openings in the ear, nose, throat or mouth structures.

FIG. 10 shows a perspective view of a probing device.

FIGS. 10A-10C show various steps of a method of using the probing deviceshown in FIG. 10 to access an anatomical region.

FIG. 11A shows a perspective view of a first embodiment of a dualballoon catheter that can be used to perform a diagnostic or therapeuticprocedure.

FIG. 11B shows a perspective view of a second embodiment of a dualballoon catheter that can be used to perform a diagnostic or therapeuticprocedure.

FIGS. 11C-11E show perspective views of third, fourth and fifthembodiments respectively of dual balloon catheters for dilating ananatomical region.

FIGS. 11F-11J show the various steps of a method of dilating ananatomical region using the catheter of FIG. 11D.

FIGS. 12A-12C show the various steps of a method of deploying a stent inthe ear, nose, throat or mouth using a working catheter comprising alocating mechanism.

FIGS. 12D-12H show the various steps of a method of dilating ananatomical opening in the ear, nose, throat or mouth using a combinationof a dilating device and an anchoring device.

FIG. 13 shows a perspective view of a dilating device comprising anelectrode element to reduce restenosis.

FIG. 14 shows a perspective view of an embodiment of a balloon cathetercomprising a sizing balloon and a dilating balloon.

FIG. 14A shows a crossectional view through the plane 14A-14A of FIG.14.

FIGS. 14B-14D show the various steps of dilating an anatomical openingusing the balloon catheter in FIG. 14.

FIG. 15 shows a perspective view of a balloon catheter comprising asleeve for delivering diagnostic or therapeutic agents.

FIG. 15A shows a crossectional view through plane 15A-15A of FIG. 15.

FIG. 16 shows a perspective view of a balloon catheter comprising one ormore agent delivery reservoirs.

FIG. 16A shows a crossectional view through plane 16A-16A of FIG. 16.

FIG. 17 shows a perspective view of a balloon catheter comprising aballoon comprising one or more micropores.

FIG. 17A shows a crossectional view through the plane 17A-17A of FIG.17.

FIG. 18 shows a balloon catheter comprising a balloon having an outercoating of diagnostic or therapeutic agents.

FIGS. 18A-18C show the steps of a method of using the balloon catheterof FIG. 18 to dilate an anatomical region.

FIG. 19A shows a perspective view of a lavage catheter.

FIG. 19B shows a crossectional view through the plane 19B-19B of FIG.19A.

FIG. 19C shows the method of operation of lavage catheter of FIG. 19A tolavage an anatomical region.

FIG. 20A shows a perspective view of the distal end of a secondembodiment of a lavage catheter.

FIG. 20B shows a perspective view of the distal end of the lavagecatheter of FIG. 20A introduced in an anatomical region.

FIG. 20C shows an embodiment of the lavage catheter of FIG. 20A beingused to lavage an anatomical region.

FIG. 20D shows a sagittal section of a human head showing the generalworking environment of the lavage devices of FIGS. 20A-20C.

FIG. 21 shows a perspective view of a cutting device comprising cuttingjaws.

FIG. 21A shows a perspective view of the distal region of the cuttingdevice of FIG. 21 wherein the cutting jaws are closed as seen from thedistal end of the cutting device.

FIG. 21B shows a perspective view of one embodiment of the cutting jawsof the cuffing device of FIG. 21.

FIG. 21C shows a crossectional view of the cutting device in FIG. 21through cutting plane 21C-21C.

FIG. 22A shows a perspective view of an alternate embodiment of a devicecomprising cutting or gripping jaws.

FIG. 22B shows a perspective view of the device of FIG. 22A wherein thecutting or gripping jaws of the cutting device are in a closedconfiguration.

FIGS. 23A-23C show the various steps of a method of puncturing ananatomical region using a flexible, rotating drill shaft.

FIG. 23D shows a sectional view of an embodiment of a drilling device.

FIGS. 24A-24C show a sagittal section of an Ethmoid sinus showingvarious methods of treating Ethmoid sinus diseases by a minimallyinvasive approach.

FIGS. 24A′-24A″″ show a method of creating drainage channels for sinussecretions in Ethmoid sinus.

FIG. 25A shows a perspective view of an embodiment of an ostium enlargerand/or microshaver.

FIG. 25B shows one embodiment of the device of FIG. 25A being used toremove tissue or matter.

FIG. 25C shown another embodiment of the device of FIG. 25A being usedto shave tissue or matter.

FIG. 25D is an exploded view of the device of FIG. 25C.

FIGS. 26A-26C show various steps of a method of treating a mucocyst by apuncturing needle and a balloon catheter.

FIGS. 27A-27B show various steps of a method of treating a mucocyst by aballoon catheter comprising a deployable puncturing needle.

FIGS. 28A-28C show various embodiments of catheters comprising agentdelivery needles.

FIG. 29A illustrates an embodiment of a displacement catheter todisplace and remove secretions in an anatomical region.

FIG. 29B shows a sectional view of an anatomical region showing a methodof displacing secretions by the displacement catheter of FIG. 29A.

FIG. 30 shows a perspective view of an embodiment of an ultrasonicdrilling device.

FIGS. 30A-30B show a sectional view of an anatomical region showing amethod of expanding an anatomical opening using the drilling device ofFIG. 30.

FIG. 31 shows a sectional view of an embodiment of a catheter forproviding an internal cast for fractured bony cavities.

FIG. 31A shows a crossection through the outer balloon in the catheterof FIG. 31 through plane 31A-31A.

FIGS. 31B-31D show various steps of a method of providing an internalcast for a fractured bony cavity using the catheter shown in FIG. 31

FIG. 32 shows an embodiment of a surgical navigation system comprisingelectromagnetic sensors.

FIG. 32A shows an enlarged view of region 32A in FIG. 32.

FIG. 33 shows a section of the anatomical region around a Eustachiantube (ET) showing a diagnostic or therapeutic procedure being performedby devices inserted through the pharyngeal ostium of the Eustachiantube.

FIG. 33A shows an enlarged view of region 33A in FIG. 33.

FIG. 33B shows a front view of a human head with a portion of the faceremoved to show an embodiment of a method of introducing a guidewireinto a Eustachian tube.

FIGS. 34A-34D illustrate various examples of working elements that couldbe located on the diagnostic or therapeutic device in FIG. 33.

FIG. 35 shows a perspective view of an embodiment of a guidewirecomprising a sensor used for surgical navigation.

FIG. 35A shows an enlarged view of an embodiment of a low profileproximal region of the guidewire in FIG. 35.

FIG. 35B shows a perspective view of a method of advancing a diagnosticor therapeutic device over the guidewire in FIG. 35.

FIG. 35C shows a perspective view of an embodiment of a guidewirecomprising a sensor having a diagnostic or therapeutic device preloadedon the guidewire.

FIG. 35D shows a perspective view of a second embodiment of a guidewirecomprising a sensor having a diagnostic or therapeutic device preloadedon the guidewire.

DETAILED DESCRIPTION

The following detailed description, the accompanying drawings and theabove-set-forth Brief Description of the Drawings are intended todescribe some, but not necessarily all, examples or embodiments of theinvention. The contents of this detailed description, the accompanyingdrawings and the above-set-forth Brief Description of the Drawings donot limit the scope of the invention in any way.

A number of the drawings in this patent application show anatomicalstructures of the ear, nose and throat. In general, these anatomicalstructures are labeled with the following reference letters: NasalCavity NC Nasopharynx NP Frontal Sinus FS Frontal Sinus Ostium FSOEthmoid Sinus ES Ethmoid Air Cells EAC Sphenoid Sinus SS Sphenoid SinusOstium SSO Maxillary Sinus MS Maxillary sinus ostium MSO Mucocyst MCEustachian tube ET Cochlea C Tympanic cavity TC Middle turbinate MTInferior turbinate IT Uncinate UN

FIG. 1 shows a schematic diagram of the general working environment ofan example of a system for catheter-based minimally invasive sinussurgery being used to perform a sinus surgery on a human patient. Thehuman patient is treated by a working device 10. Working device 10 maybe connected to one or more auxiliary devices located on a treatmenttray 12. A C-arm fluoroscope 14 provides fluoroscopic visualization ofanatomical regions during the procedure. An instrument console 16comprising one or more functional modules 18 may also be present.Examples of functional modules that can be used with the invention are:

-   -   1. Suction pump for delivering a controlled amount of negative        pressure or vacuum to a suction device,    -   2. Irrigation pump to deliver saline, antibiotic solution or        other suitable irrigation medium,    -   3. Power module to supply power to drills or other electrical        devices,    -   4. Storage modules for storing instruments, medications etc.,    -   5. Energy delivery module to provide radiofrequency, laser,        ultrasound or other therapeutic energy to a surgical device,    -   6. Fluoroscope, MRI, CT, Video, Endoscope or Camera or other        imaging modules to connect or interact with devices used during        various diagnostic or therapeutic procedures,    -   7. Display module e.g. a LCD, CRT or Holographic screen to        display data from various modules such as an endoscope,        fluoroscope or other data or imaging module,    -   8. Remote control module to enable an operator to control one or        more parameters of one or more functional modules 18,    -   9. Programmable Microprocessor that can store one or more        operation settings for one or more functional modules 18 etc.,        and    -   10. Stabilization device for holding various apparatuses during        the procedure which may include a stabilization arm, table,        clip, intranasal or extranasal inflatable support or robotically        controlled apparatus,    -   11. Rotary drive module for rotating rotatable device such as a        drill or auger (e.g., a motor having a rotation drive shaft or        drive cable attached thereto.

One or more functional modules 18 may be connected to the working device10. Instrument console module 16 can be controlled by console controlmeans 20, e.g. a foot pedal controller, a remote controller etc.Instrument console 16 may be fitted with wheels to enable an operator tochange the position of the instrument console 16 in an operating area.In one embodiment, instrument console module 16 and C-arm fluoroscope 14are integrated in a single unit.

FIG. 1A shows a magnified view of region 1A of FIG. 1 showing a systemfor catheter-based minimally invasive sinus surgery of a human patient.In FIG. 1A, a balloon catheter is used as an example of working device10. Working device 10 has attachments for a variety of auxiliary devicessuch as a balloon inflation syringe 22, a guidewire 24 and a suction orirrigation tube 26. Working device 10 and the auxiliary devices may bedetachably attached to treatment tray 12. Treatment tray 12 may compriseone or more treatment tray controllers 28 to control one or moretreatment parameters. Treatment tray 12 may comprise one or more storagemodules to store devices used during a surgery e.g. irrigation bottles,swabs etc.

FIG. 1B shows a perspective view of a treatment tray for catheter-basedminimally invasive sinus surgery of a human patient. Treatment tray 12comprises one or more device holders 30 to detachably hold devicesduring the surgery. In one embodiment, device holders 30 are detachablyattached to device holder slots 32 on treatment tray 12. Thus theposition of device holders 30 on treatment tray 12 can be changed byremoving a device holder 30 from a device holder slot 32 andtransferring to a new device holder slot 32.

FIG. 2A shows a portion of a stabilizing device 100 comprising astabilizing member 102. Stabilizing member 102 comprises a lumen throughwhich working device 10 can be introduced. In this example, stabilizingmember 102 is located in a nostril. Alternatively, stabilizing member102 may be located in other suitable regions of the head e.g. the nasalpassages.

Stabilizing member 102 may be oriented to stabilizing device 100 in avariety of orientations. Also, the stabilizing member can be used tostabilize more than one working device. FIGS. 2B-2D show variousalternate embodiments of stabilizing member 102 of FIG. 2A. FIG. 2Bshows an embodiment of a radially symmetrical stabilizing member 104,wherein the axis 106 of stabilizing member 104 is substantially parallelto the axis 110 of stabilizing device 100. FIG. 2C shows an embodimentof a radially symmetrical stabilizing member 112. The axis 114 ofstabilizing member 112 is substantially non-parallel to the axis 116 ofstabilizing device 100. FIG. 2D shows an embodiment of a stabilizingmember 118, wherein stabilizing member 118 comprises two lumensenclosing a first stabilizing device 120 and a second stabilizing device122. Suitable materials that can be used for constructing thestabilizing members are:

-   -   Foam materials such as polyurethane foam, polyvinyl chloride        foam, Thermal-Reactive Foam™ etc.,    -   Inflatable members such as compliant or non-compliant balloons,    -   Moldable materials such as silicone rubber or wax,    -   Metals such as stainless steel or super-elastic or shape memory        metals such as Nitinol    -   Thermoplastic elastomers such as block copolymers e.g.        styrene-butadiene-styrene (SBS) rubber or ionomers etc.

The stabilizing members may be pre-molded to a predefined shape.

FIGS. 2E-2G show perspective views of various embodiments of inflatableoccluding devices. FIG. 2E shows a partial view of an occluding device124 comprising an inflatable occluding member 126. Inflatable occludingmember 126 may be made of compliant materials e.g. silicone rubber, ornon-compliant materials e.g. polyethylene terephthalate (PET).Inflatable occluding member 126 can be inflated through an inflationport 127 located on the occluding device 124. Occluding device 124 canhave one or more device insertion ports. The device insertion ports canbe used to insert a variety of diagnostic or therapeutic devices such asendoscopes, guidewires, catheters etc. In this example, occluding device124 has a first device insertion port 128 and a second device insertionport 130. The device insertion ports may comprise one or more flushports. In this example, occluding device 124 comprises a first flushport 132 located on first device insertion port 128 and a second flushport 134 located on second device insertion port 130. Such an occludingdevice may be used for occluding one or two nostrils to provide agas-tight or liquid-tight seal against the nostril or to stabilizedevices that are passed through the device insertion ports on theoccluding device.

The inflatable occluding member may be made of variety of shapes. FIG.2F shows an occluding device 136 comprising an inflatable occludingmember 138 of an elongated shape wherein the diameter of the inflatableoccluding member 138 tapers along the length of occluding device 136.Inflatable occluding member 138 may also be spherical, disk shaped,cylindrical, conical etc.

The inflatable occluding member may comprise a variety of surfacefeatures. For example, FIG. 2G shows an occluding device 140 comprisingan inflatable occluding member 142. Inflatable occluding membercomprises a series or parallel circular ribs on its surface. Othersurface features such as coatings (e.g. friction increasing coatings,abrasion resisting coatings, puncture resisting coatings, conductivecoatings, radiopaque coatings, echogenic coatings, thrombogenicityreducing coatings and drug releasing coatings etc.), braids, groovesetc. may also be present on inflatable occluding member 142.

FIGS. 3A-3D′ show embodiments of stabilizing members comprising anadhesive element. FIG. 3A shows front view of an embodiment of astabilizing member 200 comprising a pair of upper wings 202 and a pairof lower wings 204. In this embodiment, upper wings 202 are larger thanlower wings 204. Stabilizing member 200 further comprises one or moreorifices 206 through which one or more working devices can beintroduced. Stabilizing member 200 is made of a light weight, flexiblematerial that conforms to the contours of the patient's body. Examplesof such materials are woven and non-woven fabrics, plastic films (e.g.polyvinylchloride films, polypropylene films etc.), cellulose, paperetc. Stabilizing member 200 may have a porous structure for increasedtransmission of water vapor produced in perspiration from the skin understabilizing member 200. One surface of stabilizing member 200 is coatedwith an adhesive to enable stabilizing member 200 to adhere to a surfaceon a patient's body. A non-allergenic adhesive is used to minimize skinirritation. Examples of such adhesives are non-allergenicpressure-sensitive adhesives such as silicone pressure sensitiveadhesives, rubber pressure sensitive adhesives and acrylic or hydrogelpressure sensitive adhesives. Stabilization member 200 may also belubricated with a silicone or other biocompatible lubricant at theorifice to allow easier introduction and removal of devices.

Stabilizing member 200 may be used to stabilize one or more workingdevices. FIG. 3B shows a front view of stabilizing member 200 of FIG. 3Awith two working devices: a first working device 208 and a secondworking device 210. FIG. 3C shows a front view of the stabilizing member200 of FIG. 3A with a single working device 212.

FIG. 3D shows a side view of stabilizing member 200 of FIG. 3A attachedto a patient's body. Upper wings 202 are attached on the nose of thepatient. Lower wings 204 are attached above the upper lip of thepatient. A working device 10 is introduced through the orifice 206 intothe patient's nose. FIG. 3D′ shows a front view of stabilizing member200 of FIG. 3A attached to a patient's body.

FIGS. 4A and 4B show perspective views of an occluding device indeflated and inflated states respectively. Occluding device 300comprises a shaft 302 and an inflatable balloon 304 located on distalregion of shaft 302. Shaft 302 has a diameter D.sub.1 and inflatableballoon 304 has a diameter D.sub.2 in the deflated state, whereinD.sub.2 is greater then D.sub.1. Inflatable balloon 304 can be made ofcompliant materials e.g. polyurethane, silicone etc. or non-compliantmaterials e.g. polyethylene terephthalate etc. Inflatable balloon 304can be inflated through balloon inflation port 306 located on proximalregion of occluding device 300. The inflated diameter D.sub.3 of theinflatable balloon is greater than D.sub.2 and is particularly suitablefor occluding the Nasopharynx. Occluding device 300 further comprises aseries of aspiration ports 308 located proximal to inflatable balloon304. Aspiration ports 308 are connected to an aspiration lumen 310 toaspirate contents proximal to inflatable balloon 304.

Any diagnostic or therapeutic device disclosed herein may comprise oneor more malleable regions. For example, FIG. 5 shows a perspective viewof a guide catheter comprising a plastically deformable (malleable)region. Guide catheter 400 comprises a shaft 402 comprising a malleableregion 404 located on distal region of shaft 402. Shaft 402 may comprisestiffening elements e.g. a braid, hypotube etc. Malleable region 404 maycomprise malleable metallic tubes, rods (e.g. rods embedded in shaft 402etc.), wires etc. Examples of metals that can be used for constructingmalleable region 404 are malleable stainless steel, fully annealedstainless steel, copper, aluminum etc. Guide catheter 400 furthercomprises a threaded luer 406 located on proximal end of shaft 402. Inthis example, malleable region 404 is located on distal end of guidecatheter 400. Malleable region 404 can also be located on proximalregion or any other intermediate region on shaft 402. Shaft 402 may alsocomprise more than one malleable regions. Such a design comprising oneor more malleable regions can be used for any of the devices mentionedherein such as catheters with working elements, guide catheters, guidecatheters with a pre-set shape, steerable guide catheters, steerablecatheters, guidewires, guidewires with a pre-set shape, steerableguidewires, ports, introducers, sheaths or other diagnostic ortherapeutic devices.

FIG. 6 shows a perspective view of a guide catheter comprising alubricious layer. Guide catheter 500 comprises a shaft 502 comprising athreaded luer 504 located on the proximal end of the shaft 502. FIG. 6Ashows a crossectional view of the guide catheter of FIG. 6 through theplane 6A-6A. Shaft 502 comprises a braid 506 embedded in the shaft.Shaft 502 further comprises a lubricious layer 508 located on the innersurface of shaft 502. Lubricious layer 508 may be made of suitablematerials such as Teflon liners, Teflon coatings or Teflon sheaths. Sucha design comprising one or more lubricious layers can be used for any ofthe devices mentioned herein such as catheters with working elements,guide catheters, guide catheters with a pre-set shape, steerable guidecatheters, steerable catheters, guidewires, guidewires with a pre-setshape, steerable guidewires, ports, introducers, sheaths or otherdiagnostic or therapeutic devices.

FIG. 7 shows perspective view of an embodiment of a guide cathetercomprising a straight hypotube. Guide catheter 600 comprises a tubularelement 602 and a hypotube 604 attached to the external surface oftubular element 602. Suitable materials for constructing hypotube 604are Stainless Steel 304, Nitinol etc. In one embodiment, hypotube 604 isannealed to the external surface of tubular element 602. Tubular element602 can be made from a variety of materials including Pebax, HDPE etc.Tubular element 602 may comprise a braid or a jacket. In an embodiment,tubular element 602 comprises a lubricious coating 605 on its innersurface. The lubricious coating 605 can be made of suitable lubriciousmaterials such as Teflon. In an embodiment, tubular element 602comprises a bent or angled region near the distal end of tubular element602. The bent or angled region may enclose an angle from 0 degrees to180 degrees. Further this bent or angled region may be further bent outof plane to present a compound three-dimension end shape. Hypotube 604can be malleable or substantially stiff. A malleable hypotube can beused in situations where the guide catheter 600 has to be bent ordistorted to optimize its shape to conform to a patient's anatomy.Examples of materials that can be used to make a malleable hypotube aremalleable stainless steel, fully annealed stainless steel, copper,aluminum etc. A substantially stiff hypotube can be used in situationswhere extra support is needed for introduction or removal or devicesthrough guide catheter 600. Examples of materials that can be used tomake a substantially stiff hypotube are Stainless Steel 304, Nitinoletc. Hypotube 604 may be bent to a two-dimensional or three-dimensionalshape. Distal tip of tubular element 602 may comprise a radio-opaquemarker 606 e.g. a standard radio-opaque marker band. The proximal regionof tubular element 602 comprises a threaded luer.

FIG. 7A shows a crossectional view of guide catheter 600 of FIG. 7through plane 7A-7A. The crossection of guide catheter 600 shows anouter hypotube 604 enclosing a tubular member 602 which in turncomprises a lubricious coating 605 located on the inner surface oftubular member 602.

FIG. 8 shows a perspective view of a second embodiment of a guidecatheter comprising a straight hypotube. Guide catheter 700 comprises ahypotube 702. Proximal end of hypotube 702 may comprise a threaded luer704. Hypotube 702 encloses a tubular liner 706 that protrudes from thedistal end of hypotube 702. Suitable materials for constructing tubularliner 706 are PTFE, Nylon, PEEK etc. Distal region of tubular liner 706is covered with a tubular element 708. Tubular element 708 may beconstructed of suitable materials such as Pebax, HDPE, Nylon etc. andmay comprise a braid. Proximal end of tubular element 708 may be bondedto distal end of hypotube 702 or may overlap distal region of hypotube702. In one embodiment, distal region of tubular element 708 comprises abent or angled region. In another embodiment, stiffness of tubularelement 708 varies along the length of tubular element 708. Tubularelement 708 may comprise a radio-opaque marker band 710 near distal endof tubular element 708. FIG. 8A shows a crossectional view of guidecatheter 700 of FIG. 8 through plane 8A-8A showing hypotube 702 andtubular liner 706. FIG. 8B shows a crossectional view of guide catheter700 of FIG. 8 through plane 8B-8B showing tubular element 708 andtubular liner 706.

The hypotubes disclosed above may be malleable or non-malleable. Theymay also comprise one or more bent or angled regions. For example, FIG.8C shows a perspective view of an embodiment of a guide cathetercomprising a curved or bent hypotube to facilitate access to the frontalsinuses. Guide catheter 712 comprises a hypotube 714 comprising athreaded luer 716 at the proximal end of hypotube 714. Hypotube 714 maycomprise one or more bent or angled regions. In this embodiment, thebent or angled region encloses an angle ranging from 60 degrees to 180degrees. Hypotube 714 may be malleable or non-malleable. In thisexample, hypotube 714 encloses a tubular element 718. Tubular element718 may be constructed of suitable materials such as Pebax, HDPE etc.The distal region of tubular element 718 comprises a bent or angledregion. In this embodiment, the bent or angled region encloses an angleranging from 60 degrees to 170 degrees to facilitate access to thefrontal sinuses using guide catheter 712. Distal region of tubularelement 718 may comprise a radio-opaque marker 720. FIG. 8D shows aperspective view of a second embodiment of a guide catheter comprising acurved or bent hypotube to facilitate access to the sphenoid sinuses.The catheter construction is similar to the catheter in FIG. 8C exceptthe bent or angled region of hypotube 714 encloses an angle ranging from90 degrees to 180 degrees and the bent or angled region of tubularelement 718 encloses an angle ranging from 120 degrees to 180 degrees.

FIG. 8E shows a perspective view of an embodiment of a guide cathetercomprising two bent or angled or curved regions to facilitate access tothe maxillary sinuses. Guide catheter 740 comprises a tubular element742 comprising a threaded luer 744 at the proximal end of tubularelement 742. Tubular element 742 further comprises a proximal bent,curved or angled region 746 enclosing an angle ranging from 90 degreesto 180 degrees and a distal bent, curved or angled region 748 enclosingan angle ranging from 90 degrees to 180 degrees. Tubular element 742 canbe constructed from a variety of biocompatible materials such as Pebax,HDPE, Nylon, PEEK etc. and may comprise a braid. The inner surface oftubular element 742 may comprise a lubricious layer e.g. a Teflon layer.A curved region 750 is attached to the distal end of tubular element742. Curved region 750 may enclose an angle ranging from 75 degrees to180 degrees. The stiffness of curved region 750 is more than thestiffness of tubular element 742 so that there is no significant changeto the shape of curved region 750 during the operation of guide catheter740. The distal end of curved region 750 comprises a soft, atraumatictip 752. The distal end of curved region 750 may also comprise aradioopaque marker. Guide catheter 740 may be further bent out of planeto present a compound three-dimension end shape. FIG. 8F shows aperspective view of a second embodiment of a guide catheter comprisingtwo bent or angled or curved regions and a hypotube to facilitate accessto the maxillary sinuses. The construction of guide catheter 754 issimilar to guide catheter 740 in FIG. 8E except that guide catheter 754further comprises a hypotube 756 on the outer surface of the proximalregion of guide catheter 754.

FIG. 8G shows a coronal section of the paranasal anatomy showing amethod of accessing a maxillary sinus ostium using guide catheter 754 ofFIG. 8F. Guide catheter 754 is introduced through a nostril and advancedin the paranasal anatomy such that atraumatic tip 752 is located insideor adjacent to a maxillary sinus ostium MSO. Proximal bent, curved orangled region 746 allows guide catheter 754 to be positioned around theinferior turbinate IT. Similarly, distal bent, curved or angled region748 allows guide catheter 754 to be positioned around the middleturbinate MT. A guidewire or a suitable diagnostic or therapeutic devicemay then be introduced through the lumen of guide catheter 754 into themaxillary sinus MS. FIG. 8H shows a sagittal section of the paranasalanatomy showing the method of FIG. 8G to access a maxillary sinus ostiumusing guide catheter 754 of FIG. 8F.

FIG. 8I shows a perspective view of an example of a guide cathetercomprising a common proximal portion and a plurality of detachabledistal tips. Distal end of common proximal portion 760 attaches toproximal end of a first detachable tip 762 by an attachment mechanism.First detachable tip 762 comprises an angled, curved or bent regionenclosing an angle of 80-110 degrees suitable for access to the frontaland ethmoid sinuses. Similarly, distal end of common proximal portion760 attaches to proximal end of a second detachable tip 764 by anattachment mechanism. Second detachable tip comprises two angled, curvedor bent regions enclosing angles of 80-110 degrees and 80-110 degreesrespectively. Such a design is suitable for access to the maxillarysinuses. Examples of attachment mechanisms are screw mechanisms, snapfitting mechanisms, slide fit mechanisms etc. Distal end of firstdetachable tip 762 and second detachable tip 764 may comprise aradioopaque marker such as a radioopaque band. Such a design comprisingdetachable distal regions can be used in a variety of diagnostic ortherapeutic devices discloses herein. It can be used for easy access toone or more anatomical regions in the ear, nose, throat or mouth byusing multiple detachable distal tips, wherein each detachable tip isoptimized for access to a particular anatomical region.

FIG. 9 shows a perspective view of a set of devices to dilate or modifyostia or other openings in the ear, nose, throat or mouth structures.Guide catheter 800 comprises a shaft 802 comprising a threaded luer 804at proximal end of shaft 802. Distal end of shaft 802 comprises aradio-opaque marker band MB to enable the physician to identify the tipof shaft 802 in a fluoroscopic image. The distal end of shaft 802 may besubstantially straight or may comprise one or more bent or angledregions. One or more distance markings DM may also be located on theshaft 802. An optional subselective catheter 806 may also be present inthe set of devices. Subselective catheter 806 comprises a shaft 808comprising a threaded luer 810 at the proximal end of shaft 808. Innerdiameter of shaft 808 is smaller than inner diameter of shaft 802.Distal end of the shaft 808 comprises a radio-opaque marker band MB toenable the physician to identify the tip of shaft 808 in a fluoroscopicimage. Distal end of shaft 808 may be substantially straight or maycomprise one or more bent or angled regions. One or more distancemarkings DM may also be located on the shaft 808. Working device 812comprises a shaft 814 comprising a working element 816 located on distalregion of shaft 814 and a threaded luer 818 located on proximal end ofshaft 814. In this example, the working element 816 is a dilatingballoon. Other examples of working elements include dilating stents,suction or irrigation devices, needles, polypectomy tools, brushes,brushes, energy emitting devices such as ablation devices, laserdevices, image-guided devices containing sensors or transmitters,endoscopes, tissue modifying devices such as cutters, biopsy devices,devices for injecting diagnostic or therapeutic agents, drug deliverydevices such as substance eluting devices, substance delivery implantsetc. The distal end of shaft 814 may be substantially straight or maycomprise a bent or angled region. One or more distance markings DM mayalso be located on shaft 814. The set of devices further comprises aguidewire 820. Guidewire 820 may be substantially straight or maycomprise a bent or angled region. One or more distance markings DM mayalso be located on guidewire 820. In one embodiment of a method usingthe abovementioned set of devices, guide catheter 800 is introduced intoa patient's body so that distal end of guide catheter 800 is in thevicinity of an anatomical opening (e.g. an ostium) of an anatomicalregion (e.g. a paranasal sinus). Thereafter, guidewire 820 is introducedthrough guide catheter 800 into the anatomical region e.g. the paranasalsinus. If necessary, guide catheter 800 may be removed and the smallersubselective catheter 806 may be introduced over guide wire 820 into theparanasal sinus. Thereafter, working device 812 is introduced overguidewire 820 into the paranasal sinus and a diagnostic or therapeuticprocedure is performed by working device 812. In another embodiment of amethod using the abovementioned set of devices, subselective catheter806 is introduced into a patient's body so that distal end ofsubselective catheter 806 is in the vicinity of an anatomical opening(e.g. an ostium) of an anatomical region (e.g. a paranasal sinus).Thereafter, guidewire 820 is introduced through subselective catheter806 into the anatomical region e.g. the paranasal sinus. Thereafter,subselective catheter 806 is removed. Larger guide catheter 800 is thenintroduced over guide wire 820. Working device 812 is then introducedover guidewire 820 into the paranasal sinus and a diagnostic ortherapeutic procedure is performed by working device 812. This methodembodiment enables a user to introduce larger working device 812 in theanatomical region.

FIG. 10 shows a perspective view of a probing device. The probing device900 comprises a probing element 902 and a detachable handle 904. Probingelement 902 comprises an atraumatic tip 906 located on the distal end ofprobing element 902. In one embodiment, atraumatic tip 906 is spherical.Probing element 902 can be made from a variety of biocompatiblematerials such as metals (e.g. stainless steel, titanium, Nitinol etc.)or polymers (e.g. Pebax, polyethylene etc.). Probing element 902 may berigid or flexible or malleable. In the embodiment shown in FIG. 10, thedistal region of the probing element 902 is malleable. This enables aphysician to adjust probing device 900 for a patient's unique anatomy.Probing element 902 may comprise one or more curved or angled regions.Length of probing element 902 can range from 10 centimeters to 30centimeters. Detachable handle can be attached to the probing element902 by a variety of attachment mechanisms including screw arrangement,clipping mechanism etc. The tip of the probing element may further bemodified to include a marker, sensor or transmitter capable of beingtracked using one or more imaging modalities, such as x-ray,electromagnetic, radio-frequency, ultrasound, radiation, optics, and/orsimilar modalities.

FIGS. 10A-10C show various steps of a method of using the probing deviceshown in FIG. 10 to access an anatomical region. In FIG. 10A, probingdevice 900 is advanced in to a patient's frontal sinus ostium throughthe nasal cavity. Atraumatic tip 906 prevents the probing device 900from perforating and damaging healthy tissues. Thereafter, in FIG. 10B,detachable handle 904 is detached from probing element 902. Thereafter,in FIG. 10C, a working device 908 e.g. a catheter is advanced over theprobing element 902 into the patient's frontal sinus ostium. Workingdevice 908 can then be used to perform a diagnostic or therapeuticprocedure or introduce other devices. In this example, probing device900 was used to access the patient's frontal sinus ostium. Otheranatomical locations in the patient's body e.g. ostia of other paranasalsinuses, ostia of lachrymal ducts, regions in the Eustachian tube, ductsof salivary glands, etc. may be accessed by similar methods. It is alsopossible that working device 908 may be preloaded over probing element902 and maintained in a retracted position relative to the probingelement until distal portion of the probing element 902 is introducedinto a desired location. Further, multiple working devices may beinserted within working device 908 or over working device 908 once it isproperly positioned.

FIG. 11A shows a perspective view of a first embodiment of a dualballoon catheter that can be used to perform a diagnostic or therapeuticprocedure. Catheter 1000 comprises a catheter shaft 1002 and a proximalballoon 1004 and a distal balloon 1006 located on catheter shaft 1002. Avariety of diagnostic or therapeutic modules may be located in theinter-balloon region 1008 located between proximal balloon 1004 anddistal balloon 1006. Examples of such diagnostic or therapeutic modulesare dilating or occluding balloons, dilating stents, suction orirrigation devices, needles, polypectomy tools, energy emitting deviceslike ablation devices, laser devices, image-guided devices containingsensors or transmitters, imaging devices, endoscopes, tissue modifyingdevices like cutters, biopsy devices, devices for injecting diagnosticor therapeutic agents, lavage devices, drug delivery devices such assubstance eluting devices, substance delivery implants etc. etc. Acatheter hub 1010 is located on the proximal end of catheter shaft 1002.Catheter hub 1010 comprises a balloon inflation port 1012 that can beused to inflate both proximal balloon 1004 and distal balloon 1006.

FIG. 11B shows a perspective view of a second embodiment of a dualballoon catheter that can be used to perform a diagnostic or therapeuticprocedure. The catheter 1014 shown in this embodiment further comprisesa second balloon inflation port 1016. Balloon inflation port 1012 isused to inflate proximal balloon 1004 and second balloon inflation port1016 is used to inflate distal balloon 1006. In one embodiment of amethod using catheter 1014, distal balloon 1006 is inflated beforeproximal balloon 1004.

FIGS. 11C-11E show perspective views of third, fourth and fifthembodiments respectively of dual balloon catheters for dilating ananatomical region. In FIG. 11C, catheter 1020 comprises a catheter shaft1022 comprising a catheter hub 1024 at the proximal end of cathetershaft 1022. The distal region of catheter shaft 1022 comprises aproximal balloon 1026 and a distal balloon 1028. Proximal balloon 1026and distal balloon 1028 can be made from compliant or non-compliantmaterials. Catheter shaft 1022 further comprises a dilating balloon 1030located between proximal balloon 1026 and distal balloon 1028. Dilatingballoon 1030 is constructed from suitable non-compliant materials suchas Polyethylene terephthalate etc. The balloons are inflated throughthree balloon inflation ports located on catheter hub 1024. A firstballoon inflation port 1032 is used to inflate proximal balloon 1026, asecond balloon inflation port 1034 is used to inflate distal balloon1028 and a third balloon inflation port 1036 is used to inflate dilatingballoon 1030. FIG. 11D shows a perspective view of catheter 1020 in FIG.11C further comprising a stent 1038 disposed on dilating balloon 1030.Several types of stent designs can be used to construct stent 1038 suchas metallic tube designs, polymeric tube designs, chain-linked designs,spiral designs, rolled sheet designs, single wire designs etc. Thesedesigns may have an open celled or closed celled structure. A variety offabrication methods can be used for fabricating stent 1038 including butnot limited to laser cutting a metal or polymer element, welding metalelements etc. A variety of materials can be used for fabricating stent1038 including but not limited to metals, polymers, foam type materials,plastically deformable materials, super elastic materials etc. Somenon-limiting examples of materials that can be used to construct stent1038 are Nitinol, stainless steel, titanium, polyurethane, gelfilm,polyethylene and silicones e.g. silastic. A variety of features can beadded to stent 1038 including but not limited to radiopaque coatings,drug elution mechanisms etc. FIG. 11E shows a perspective view ofcatheter 1020 in FIG. 11C wherein proximal balloon 1026 and distalballoon 1028 are conical. Dual balloon catheters may also be used todeploy self-expanding stents at a target anatomical region.

FIGS. 11F-11J show the various steps of a method of dilating ananatomical region using the catheter of FIG. 11D. In FIG. 11F, catheter1020 is introduced into an anatomical region to be dilated. In oneembodiment, catheter 1020 is introduced over a guidewire 1040. In FIG.11G, distal balloon 1028 is inflated through second balloon inflationport 1034. Thereafter, catheter 1020 is pulled in the proximal directiontill distal balloon 1028 gets lodged in the anatomical region to bedilated. Thereafter in FIG. 11H, proximal balloon 1026 is inflatedthrough first balloon inflation port 1032. This enables catheter 1020 tobe securely lodged in the anatomical region to be dilated. Thereafter inFIG. 11I, dilating balloon 1030 is inflated through third ballooninflation port 1036. Inflated dilation balloon 1030 exerts an outwardforce on the anatomical region and causes it to dilate. This step alsodeploys stent 1038. Thereafter in FIG. 11J, proximal balloon 1026,distal balloon 1028 and dilating balloon 1030 are deflated and catheter1020 is removed by pulling catheter 1020 in the proximal direction.

FIGS. 12A-12C show the various steps of a method of deploying a stent inthe ear, nose, throat or mouth using a working catheter comprising alocating mechanism. In this example, the locating mechanism is a locatorballoon. A working device 1100 is provided that comprises a locatorballoon 1104 and a stent 1106 located on a stent deploying balloon 1108located on a catheter shaft 1110. Locator balloon 1104 is located on thedistal region of the catheter shaft 1110 and stent 1106 is locatedproximal to the locator balloon 1104. In FIG. 12A, the working device1100 is inserted into an anatomical region through an anatomical opening1111 such that the locator balloon 1104 is located distal to anatomicalopening 1111. Examples of the anatomical region are paranasal sinuses,Eustachian tubes, lachrymal ducts and other structures in the ear, nose,throat or mouth etc. Examples of anatomical opening 1111 are ostia ofparanasal sinuses, ostia of lachrymal ducts etc. In FIG. 12B, locatorballoon 1104 is inflated. The inflated diameter of the locator balloonis greater than the diameter of the anatomical opening. Working device1100 is then pulled in the proximal direction such that locator balloon1104 presses against the anatomical opening 1111. This enables stent1106 to be positioned accurately in a desired location relative toanatomical opening 1111. In FIG. 12C, stent deploying balloon 1108 isinflated to deploy stent 1106. Thereafter, stent deploying balloon 1108and locator balloon 1104 are deflated and the working device 1100 isremoved by pulling it out in the proximal direction. Similar workingcatheters comprising locating mechanisms can also be used to deployself-expanding stents.

In this example, the locating mechanism was a locator balloon. Otherexamples of locating device are deployable elements such as wire meshes,radially projecting wires, deployable devices located on guidewires(e.g. balloons, wire meshes etc.), devices deployed on pull-elements(e.g. radially expandable elements etc.) etc.

FIGS. 12D-12H show the various steps of a method of dilating ananatomical opening in the ear, nose, throat or mouth using a combinationof a dilating device and an anchoring device. In this example, thedilating device is a dilating balloon catheter and the anchoring deviceis an anchoring balloon catheter. In FIG. 12D, an anchoring ballooncatheter 1120 comprising a catheter shaft 1122 and an anchoring balloon1124 is inserted over a guidewire GW into an anatomical opening. In oneembodiment, shaft 1122 of anchoring balloon catheter 1120 is coated witha lubricious coating such as Teflon. In this example the anatomicalopening is the sphenoid sinus ostium SSO of a sphenoid sinus SS. In FIG.12E, anchoring balloon 1124 is inflated. The inflated diameter ofanchoring balloon 1124 is greater than the diameter of the anatomicalopening. Thereafter, anchoring balloon catheter 1120 is pulled in theproximal direction so that anchoring balloon 1124 is anchored in theanatomical opening. In FIG. 12F, a dilating balloon catheter 1126comprising a shaft 1128 and a dilating balloon 1130 is advanced in theproximal direction over shaft 1122 of anchoring balloon catheter 1120.Dilating balloon catheter 1126 is advanced till the distal portion ofdilating balloon catheter 1126 touches anchoring balloon 1124. Thisdesign accurately positions dilating balloon 1130 in a target locationin the anatomical opening. Thereafter, in FIG. 12G, dilating balloon1130 is inflated to dilate the anatomical opening. Thereafter, in FIG.12H, the dilating balloon 1130 and anchoring balloon 1124 are deflatedand dilating balloon catheter 1126 and anchoring balloon catheter 1120are withdrawn from the anatomical opening by pulling them in theproximal direction. Dilating balloon 1130 can be made of suitablenon-compliant materials e.g. polyethylene terephthalate etc. Anchoringballoon 1124 can be made of suitable compliant materials e.g.polyurethane, silicone etc. or non-compliant materials e.g. polyethyleneterephthalate etc. Examples of anchoring devices are catheterscomprising balloons, deployable elements such as wire meshes, radiallyprojecting wires; deployable devices located on guidewires (e.g.balloons, wire meshes etc.); devices deployed on pull-elements (e.g.radially expandable elements etc.) etc.

Such a combination of an anchoring device and a working device insertedalong the anchoring device can be used for a variety of other methodsand devices disclosed herein for treating anatomical openings such asostia of paranasal sinuses, ostia of lachrymal ducts, ducts of salivaryglands, Eustachian tubes and other ear, nose, throat or mouth structuresetc.

FIG. 13 shows a perspective view of a dilating device comprising anelectrode element to reduce restenosis. Dilating device 1200 comprises ashaft 1202 and a dilating element 1204 located on the distal region ofshaft 1202. Examples of dilating elements are non-compliant dilatingballoons, mechanically expandable elements etc. Dilating device 1200further comprises an electrode element 1206 located on dilating element1204. Electrode element 1206 in combination with one or more surfaceelectrodes attached to a surface of a patient's body delivers electricalenergy to an anatomical region to be dilated. The electrical energycauses a controlled destruction of the adjacent anatomical regionthereby reducing the risk to restenosis of the dilated region. Electrodeelement 1206 may have a variety of configurations including meshes,wires wound in a spiral configuration, wires wound in a sinusoidalconfiguration etc. Electrode element 1206 can be constructed from avariety of biocompatible metallic materials such as platinum-iridiumalloys (e.g. 90% platinum/10% iridium) etc. Dilating device 1200 mayfurther comprise an insulating layer between electrode element 1206 anddilating element 1204. In one embodiment, electrode element 1206 islocated on a sheath that can be advanced over dilating device 1200 suchthat electrode element 1206 is located above dilating element 1204.

FIG. 14 shows a perspective view of an embodiment of a balloon cathetercomprising a sizing balloon and a dilating balloon. A portion of thesizing balloon has been removed to show the dilating balloon underneaththe sizing balloon. Balloon catheter 1300 comprises a shaft 1302 and adilating balloon 1304 located on distal region of shaft 1302. Dilatingballoon 1304 can be made of suitable non-compliant materials e.g.polyethylene terephthalate, Nylon etc. Dilating balloon 1304 is inflatedthrough a first balloon inflation opening 1305. Balloon catheter 1300further comprises a sizing balloon 1306 located around dilating balloon1304. Sizing balloon 1306 is made from a compliant or semi-compliantmaterial such as crosslinked polyethylene or other polyolefins,polyurethane, flexible polyvinylchloride, Nylon etc. Sizing balloon 1306is inflated through a second balloon inflation opening 1307. Dilatingballoon 1304 and sizing balloon 1306 enclose an inter-balloon volume1308. FIG. 14A shows a crossection of the balloon catheter in FIG. 14through plane 14A-14A. Shaft 1302 comprises a guidewire lumen 1310, afirst inflation lumen 1312 that terminates distally in first ballooninflation opening 1305 of FIG. 14, and a second inflation lumen 1314that terminates distally in second balloon inflation opening 1307 ofFIG. 14.

FIGS. 14B-14D show the various steps of dilating an anatomical openingusing the balloon catheter in FIG. 14. In FIG. 14B, balloon catheter1300 is introduced over a guidewire GW into an anatomical opening 1316to be dilated. Examples of the types of anatomical openings 1316 thatmay be dilated by this invention include ostia of paranasal sinuses,Eustachian tubes, ostia of lachrymal ducts, etc. Thereafter, in FIG.14C, sizing balloon 1306 is inflated using an imagable inflating medium.Examples of suitable imagable inflating media are saline with aradioopaque contrast agent, carbon dioxide gas etc. Distal region ofballoon catheter 1300 is subsequently imaged using a suitable imagingmodality such as fluoroscopy or X-rays. This enables an operator toaccurately estimate the size of anatomical opening 1316. Such a ballooncatheter is also suited for estimating the diameter of the narrowestregion in a tubular anatomical region e.g. a Eustachian tube prior toperforming a diagnostic or therapeutic procedure such as balloondilation. On the basis of information obtained during step 14C, ballooncatheter 1300 may be repositioned and step 14C repeated if necessary.Thereafter, in step 14D, sizing balloon 1306 is deflated. Also in step14D, dilating balloon 1304 is inflated to dilate a target region inanatomical opening 1316. Thereafter, dilating balloon 1304 is deflatedand balloon catheter 1300 is withdrawn from anatomical opening 1316. Inone embodiment, sizing balloon 1306 may be reinflated after a balloondilation procedure to obtain feedback about the performance of theballoon dilation procedure.

FIG. 15 shows a perspective view of a balloon catheter 1400 fordelivering diagnostic or therapeutic agents. This balloon catheter 1400comprises a catheter shaft 1402 which may be flexible, malleable orrigid, and a dilating balloon 1404 located on the distal region of shaft1402. Dilating balloon 1404 can be made of any suitable compliant ornon-compliant materials (e.g. polyethylene terephthalate etc.). An outerballoon or sheath 1406 covers the dilating balloon 1404, as shown in thecut-away view of FIG. 15. Sheath 1406 can be made of suitablenon-compliant materials e.g. polyethylene terephthalate etc. orcompliant or semi-compliant materials such as crosslinked polyethyleneor other polyolefins, polyurethane, flexible polyvinylchloride, Nylonetc. Sheath 1406 comprises one or more pores 1408 through whichdiagnostic or therapeutic agents can be delivered to the surroundinganatomy. Pores 1408 may have a pore size ranging from sub-micron to afew microns. Dilating balloon 1404 is inflated by a balloon inflationlumen 1410. The diagnostic or therapeutic agents can be delivered to theregion between sheath 1406 and dilating balloon 1404 by an agentdelivery lumen 1412. In this particular embodiment, sheath 1406 isattached to shaft 1402. FIG. 15A shows a crossection through the plane15A-15A of FIG. 15 showing shaft 1402 comprising balloon inflation lumen1410, agent delivery lumen 1412 and a guidewire lumen 1414.

FIG. 16 shows a perspective view of a balloon catheter comprising one ormore agent delivery reservoirs. Balloon catheter 1500 comprises a shaft1502 and a balloon 1504 located on the distal region of shaft 1502.Balloon 1504 may be made from suitable compliant or semi-compliantmaterial such as crosslinked polyethylene or other polyolefins,polyurethane, flexible polyvinylchloride, Nylon, etc., or fromnon-compliant materials such as polyurethane, etc. Balloon catheter 1500further comprises one or more agent delivery reservoirs 1506 located onballoon 1504. Agent delivery reservoirs 1506 contain one or morediagnostic or therapeutic agents absorbed in a matrix. Examples ofdiagnostic or therapeutic agents are contrast agents, pharmaceuticallyacceptable salt or dosage form of an antimicrobial agent (e.g.,antibiotic, antiviral, anti-parasitic, antifungal, etc.), acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an anesthetic agent with or withoutvasoconstrictor (e.g., Xylocaine with or without epinephrine, Tetracainewith or without epinephrine), an analgesic agent, an agent that preventsof modifies an allergic response (e.g., an antihistamine, cytokineinhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator), anallergen or another substance that causes secretion of mucous bytissues, anti-proliferative agents, hemostatic agents to stop bleeding,cytotoxic agents e.g. alcohol, biological agents such as proteinmolecules, stem cells, genes or gene therapy preparations etc. Whenballoon 1504 is inflated to dilate an anatomical region, it exertspressure on agent delivery reservoirs 1506. This pressure squeezes outthe one or more diagnostic or therapeutic agents absorbed in the matrixand causes them to be released into the anatomical region. In oneembodiment, agent delivery reservoirs 1506 comprise diagnostic ortherapeutic agents absorbed in a porous matrix formed of a porousmaterial such as a flexible or rigid polymer foam, cotton wadding,gauze, etc. Examples of biodegradable polymers that may be foamed orotherwise rendered porous include polyglycolide, poly-L-lactide,poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone,polygluconate, polylactic acid-polyethylene oxide copolymers, modifiedcellulose, collagen, polyorthoesters, polyhydroxybutyrate,polyanhydride, polyphosphoester, poly(alpha-hydroxy acid) andcombinations thereof. Examples of non-biodegradable polymers that may befoamed or otherwise rendered porous include polyurethane, polycarbonate,silicone elastomers etc. FIG. 16A shows a crossection view through plane16A-16A of FIG. 16 showing shaft 1502 comprising a balloon inflationlumen 1508 and a guidewire lumen 1510.

FIG. 17 shows a perspective view of a balloon catheter comprising aballoon comprising one or more micropores or openings. Balloon catheter1600 comprises a shaft 1602 comprising a dilating balloon 1604 locatedon the distal region of shaft 1602. Dilating balloon 1604 can be made ofsuitable non-compliant materials e.g. polyethylene terephthalate etc.Dilating balloon 1604 comprises one or more micropores 1606 of a poresize ranging from submicron (e.g. 0.5 micron) to a few microns.Micropores 1606 can be formed on material of dilating balloon 1604 byvarious processes including mechanical punching, mechanical drilling,irradiation e.g. directing a laser beam or an ion or electron beam atthe balloon material etc. Dilating balloon 1604 is inflated using aninflating medium comprising one or more diagnostic or therapeutic agentsto be delivered to a target anatomical region such as ostia of paranasalsinuses, ostia of lachrymal ducts, ducts of salivary glands, Eustachiantubes etc. Examples of diagnostic or therapeutic agents are contrastagents, pharmaceutically acceptable salt or dosage form of anantimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic,antifungal, etc.), an anesthetic agent, an analgesic agent, acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen oranother substance that causes secretion of mucous by tissues,anti-proliferative agents, hemostatic agents to stop bleeding, cytotoxicagents e.g. alcohol, biological agents such as protein molecules, stemcells, genes or gene therapy preparations etc. When dilating balloon1604 is inflated, a portion of the inflating medium seeps out ofdilating balloon 1604 through micropores 1606 and thus is delivered tothe adjacent anatomical regions. Thus dilation and agent delivery can beachieved in a single step. FIG. 17A shows a crossectional view throughthe plane 17A-17A of FIG. 17 showing shaft 1602 comprising a guidewirelumen 1608 and a balloon inflation lumen 1610.

FIG. 18 shows a balloon catheter comprising a balloon having an outercoating of diagnostic or therapeutic agents. Balloon catheter 1700comprises a shaft 1702 and a dilating balloon 1704 located on the distalregion of shaft 1702. Dilating balloon 1704 can be made of suitablenon-compliant materials e.g. polyethylene terephthalate etc. Dilatingballoon 1704 comprises a coating 1706 of one or more diagnostic ortherapeutic agents on the outer surface of dilating balloon 1704.Coating 1706 may comprise diagnostic or therapeutic agents located in asuitable carrier medium. In one embodiment, the carrier medium is ahydrogel. In another embodiment, the carrier medium is a solid havingthe consistency of wax e.g. sterile bone wax. In another embodiment, thecarrier containing the agents can be deposited on the outer surface ofdilating balloon 1704 just before balloon catheter 1700 is used forperforming a diagnostic or therapeutic procedure. Coating 1706 may bepresent on the surface of dilating balloon 1704 in a variety ofconfigurations. In one embodiment, coating 1706 is in the form ofparallel strips of a carrier medium comprising one or more diagnostic ortherapeutic agents. The coating may also be in the form of an annularlayer, a plurality of discrete spots etc. When dilating balloon 1704 isinflated to dilate an anatomical region, coating 1706 comes into contactwith the adjacent anatomical region. A portion of coating 1706 isdeposited on the adjacent anatomical region which delivers thediagnostic or therapeutic agents to the adjacent anatomical region. Thusdilation and agent delivery can be achieved in a single step. In oneembodiment, coating 1706 comprises a hemostatic material with aconsistency of bone-wax.

FIGS. 18A-18C show the steps of a method of using the balloon catheterof FIG. 18 to dilate an anatomical region. In FIG. 18A, balloon catheter1700 is introduced in an anatomical region 1708. Balloon catheter 1700is positioned such dilating balloon 1704 is located in the target regionto be dilated. Thereafter, in FIG. 18B, dilating balloon 1704 isinflated. This dilates anatomical region 1708 and deposits a portion ofcoating 1706 on the dilated region. Thereafter, in FIG. 18C, dilatingballoon 1704 is deflated and balloon catheter 1700 is withdrawn fromanatomical region 1708 leaving behind a deposited layer 1710 of coating1706 on the dilated anatomical region 1708.

FIG. 19A shows a perspective view of a lavage catheter. Lavage catheter1800 comprises a shaft 1802 and an occluding balloon 1804 located on thedistal region of shaft 1802. Occluding balloon 1804 can be made ofsuitable compliant materials e.g. polyurethane, silicone etc. ornon-compliant materials e.g. polyethylene terephthalate etc. Lavagecatheter 1800 further comprises a flushing tip 1806 and an aspirationtip 1808 located on the distal end of shaft 1802. In FIG. 19A, lavagecatheter 1800 is introduced over a guidewire GW into an anatomicalregion e.g. a sphenoid sinus SS through an anatomical opening e.g. asphenoid sinus ostium SSO. FIG. 19B shows a crossectional view throughthe plane 19B-19B of FIG. 19A. Shaft 1802 comprises an aspiration lumen1810, a flushing lumen 1812 and a guidewire lumen 1814. Distal end ofaspiration lumen 1810 opens at the distal end of aspiration tip 1808 anddistal end of flushing lumen 1812 opens at the distal end of flushingtip 1806.

FIG. 19C shows the method of operation of lavage catheter 1800 of FIG.19A to lavage an anatomical region. In FIG. 19C, occluding balloon 1804is inflated and lavage catheter 1800 is pulled in the proximal directiontill occluding balloon occludes the anatomical opening e.g. sphenoidsinus ostium SSO. Thereafter, a flushing medium introduced in theanatomical region through flushing tip 1806. The flushing medium may beintroduced in lavage catheter 1800 from a flushing medium container 1816e.g. a saline bag connected to the proximal region of lavage catheter1800. The flushing medium is aspirated from the anatomical regionthrough aspiration tip 1808. The proximal end of lavage catheter 1800may be connected to a collection vessel 1818 to collect the aspiratedflushing medium. In one embodiment, collection vessel 1818 is furtherconnected to wall suction.

FIG. 20A shows a perspective view of the distal end of a secondembodiment of a lavage catheter. Lavage catheter 1900 comprises atubular member 1902 comprising a one or more openings 1904 located onthe distal region of tubular member 1902. Tubular member 1902 may bemade from a variety of materials such as silicone elastomers, Pebax,HDPE etc. Distal region of tubular member 1902 may comprise a curved orbent region. Tubular member 1902 comprises a first lumen connected toopenings 1904. Suitable diagnostic or therapeutic fluids can beintroduced or removed through openings 1904. Examples of such fluids aresaline, pharmaceutically acceptable salt or dosage form of anantimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic,antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., anNSAID), a decongestant (e.g., vasoconstrictor), a mucous thinning agent(e.g., an expectorant or mucolytic), an agent that prevents of modifiesan allergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen oranother substance that causes secretion of mucous by tissues, a contrastagent, an anesthetic agent with or without vasoconstrictor (e.g.,Xylocaine with or without epinephrine, Tetracaine with or withoutepinephrine), an analgesic agent, hemostatic agents to stop bleeding,anti-proliferative agents, cytotoxic agents e.g. alcohol, biologicalagents such as protein molecules, stem cells, genes or gene therapypreparations etc. In one embodiment, tubular member 1902 comprises asecond lumen that acts as a guidewire lumen.

FIG. 20B shows a perspective view of the distal end of the lavagecatheter of FIG. 20A introduced in an anatomical region. In thisexample, the anatomical region is a maxillary sinus MS comprising amaxillary sinus ostium MSO. Lavage catheter 1900 may be introduced intothe anatomical region by an over-the-wire method, through a cannula, orby a variety of methods disclosed in this patent application and in thepatents documents incorporated herein by reference. Other examples ofanatomical regions that can be treated using lavage catheter 1900 areother paranasal sinuses, lachrymal ducts, Eustachian tubes, and otherhollow organs in the ear, nose, throat or mouth.

FIG. 20C shows an embodiment of the lavage catheter of FIG. 20A beingused to lavage an anatomical region. In this embodiment, lavage catheter1900 further comprises an outer sheath 1910 comprising an occludingballoon 1912 located on the distal region of outer sheath 1910.Occluding balloon 1912 may be made from suitable compliant orsemi-compliant material such as crosslinked polyethylene or otherpolyolefins, polyurethane, flexible polyvinylchloride, Nylon etc. orfrom non-compliant materials such as polyurethane etc. Outer sheath 1910covers tubular member 1902 such that outer sheath and tubular member1902 enclose a suction lumen 1914 between them. Tubular member 1902 isused to introduce a lavage fluid 1916 into the anatomical region throughopenings 1904. Suction lumen 1914 is used to remove lavage fluid 1916from the anatomical region.

FIG. 20D shows a sagittal section of a human head showing the generalworking environment of the lavage devices of FIGS. 20A-20C. Distal endof lavage catheter 1900 is introduced into an anatomical region such asEthmoid air cell EAC. Lavage catheter 1900 may be introduced into theEAC by an over-the-wire method, through a cannula, or by a variety ofmethods disclosed in this patent application and in the patentsdocuments incorporated herein by reference. Proximal end of lavagecatheter 1900 is detachably connected to a irrigation and suctionapparatus 1918. Irrigation and suction apparatus 1918 provides lavagefluid 1916 to lavage catheter 1900 and also provides suction to removelavage fluid 1916 from the EAC. Lavage catheter 1900 may similarly beused to diagnose or treat other paranasal sinuses, lachrymal ducts,ducts of salivary glands, Eustachian tubes, and other hollow organs inthe ear, nose, throat or mouth.

FIG. 21 shows a perspective view of a cutting device comprising cuttingjaws. Cutting device 2000 comprises a shaft 2002 comprising an upper jaw2004 and a lower jaw 2006 located on the distal end of shaft 2002.Proximal region of shaft 2002 comprises a scissor-like device withhandles or other suitable control apparatus 2008 that is useable tocontrol the movement of upper jaw 2004 and/or lower jaw 2006. Upper jaw2004 and lower jaw 2006 are hinged together so that they can be openedor closed by scissor handles 2008 to bite, grip or cut tissue. In oneembodiment, the edges of upper jaw 2004 and lower jaw 2006 are providedwith a series of cutting teeth. Alternately, the edges of upper jaw 2004and lower jaw 2006 may be provided with sharp edges, blunt grippingteeth etc. Shaft 2002 comprises a lumen 2010. This enables cuttingdevice 2000 to be advanced over an access device such as a guidewire toaccess a target anatomical region. Examples of materials that can beused to construct cutting device 2000 are stainless steel 304, stainlesssteel 316, titanium, titanium alloys etc.

FIG. 21A shows a perspective view of the distal region of the cuttingdevice of FIG. 21 wherein the cutting jaws are closed.

FIG. 21B shows a perspective view of one embodiment of the jaws of thecutting device of FIG. 21. Upper jaw 2004 comprises an upper jaw notch2012. In one embodiment, upper jaw notch 2012 is semicircular in shape.Similarly, lower jaw 2006 comprises a lower jaw notch 2014. In oneembodiment, lower jaw notch 2014 is semicircular in shape. This designenables a guidewire to pass through a gap in the distal end of thecutting device 2000 even when upper jaw 2004 and lower jaw 2006 areclosed. In another embodiment, a guidewire passes through an openinglocated on either upper jaw 2004 or lower jaw 2006. Upper jaw 2004 andlower jaw 2006 can also be square, ovoid, trapezoidal or circular inshape.

FIG. 21C shows a crossectional view of the cutting device in FIG. 21through plane 21C-21C. Shaft 2002 of cutting device 2000 comprises alumen 2010 for an access device such as a guidewire. Shaft 2002 furthercomprises one or more pull wires 2016 that connect upper jaw 2004 andlower jaw 2006 to control apparatus 2008. When the control apparatus2008 is moved, pull wires 2016 transmit the movement to upper jaw 2004and lower jaw 2006 causing them to open or close.

FIG. 22A shows a perspective view of an alternate embodiment of a devicecomprising cutting or gripping jaws. Cutting device 2100 comprises ashaft 2102. Distal end of cutting device 2100 comprises an upper jaw2104 and a lower jaw 2106 that are hinged together at a first hinge2108. Proximal end of upper jaw 2104 comprises a first elongate member2110 and proximal end of second jaw 2106 comprises a second elongatemember 2112. The proximal end of first elongate member 2110 is connectedto a second hinge 2114 which in turn is connected to a third elongatemember 2116. Proximal end of second elongate member 2112 is connected toa third hinge 2118 which in turn is connected to a fourth elongatemember 2120. The proximal ends of third elongate member 2116 and fourthelongate member 2120 are connected by a fourth hinge 2122 to pull wire2124 that passes through shaft 2102. FIG. 22A shows cutting device 2100wherein the upper jaw 2104 and lower jaw 2106 are in an openconfiguration. When pull wire 2124 is pulled in the proximal direction,fourth hinge 2122 is pulled inside shaft 2102. This causes the distalends of third elongate member 2116 and fourth elongate member 2120 tocome closer to each other. This in turn causes the proximal ends offirst elongate member 2110 and second elongate member 2112 to comecloser to each other. This in turn causes upper jaw 2104 and lower jaw2106 close. Similarly, pushing pull wire 2124 in the distal directioncauses upper jaw 2104 and lower jaw 2106 to open. In one embodiment,cutting device 2100 comprises a spring mechanism located between pullwire 2124 and shaft 2102 that biases upper jaw 2104 and lower jaw 2106in an open or closed configuration.

FIG. 22B shows a perspective view of the device of FIG. 22A wherein thejaws of the cutting device are in a closed configuration.

FIGS. 23A-23C show the various steps of a method of puncturing ananatomical region using a flexible, rotating drill shaft. In FIG. 23A,an access catheter 2200 is introduced through a nostril to a locationadjacent to an anatomical region 2202 to be punctured. In this example,anatomical region 2202 is a maxillary sinus having a maxillary sinusostium 2204. Other examples of the types of anatomical regions 2202 areother paranasal sinuses, lachrymal ducts, bony structures in the ear,nose, throat or mouth etc. Access catheter 2200 can be made of suitablebiocompatible materials having a sufficient stiffness such as malleablestainless steel tubes; titanium tubes; fully annealed stainless steeltubes; copper tubes; aluminum tubes; tubular elements made of Pebax,HDPE etc. comprising a hypotube; etc. One or more regions of accesscatheter 2200 may be shapeable or malleable to allow a user to adjustthe shape of access catheter 2200 to a patient's unique anatomy. Asubstantially stiff access catheter 2200 can be used in situations whereextra support is needed for introduction or removal or devices throughaccess catheter 2200. In an embodiment, a lubricious coating e.g. aTeflon coating is present on the inner surface of access catheter 2200.The lubricious coating can be made of suitable lubricious materials suchas Teflon. In FIG. 23B, a flexible drill shaft 2206 is introducedthrough access catheter 2200. Access catheter 2200 helps to alignflexible drill shaft 2206 in the anatomical region 2202 in a desiredorientation. Flexible drill shaft 2206 can be designed for efficienttransfer of unidirectional or bidirectional torque. Flexible drill shaft2206 can be made from a suitable material having a high torsionalstiffness such as heat treated spring steel. Proximal end of flexibledrill shaft 2206 is connected to a reversible drive motor that is usedto rotate flexible drill shaft 2206 at a desired angular velocity.Flexible drill shaft 2206 comprises a drill bit 2208 located on thedistal end of flexible drill shaft 2206. Drill bit 2208 can range from0.5 mm-5 mm in diameter. Drill bit 2208 may be made from suitablematerials such as tungsten carbide, carbon steel, diamond powder coatedmetal etc. Drill bit 2208 can have a drill bit design such as twistdrill bit, masonry drill bit, spur point bit, step drill bit etc.Flexible drill shaft 2206 is introduced through access catheter 2202till drill bit 2208 touches a target location on anatomical region 2202to be punctured. In FIG. 23C, flexible drill shaft 2206 is rotated sothat drill bit 2208 punctures anatomical region 2202. Such a method anddevice can be used for a minimally invasive puncturing of suitableanatomical regions for drainage, aeration, introduction of diagnostic ortherapeutic devices etc. Such a device and method can also be used forenlarging or clearing natural or artificial openings in anatomicalregions. After a desired opening is created or enlarged, access catheter2200 and flexible drill shaft 2206 are withdrawn from the anatomy. Inone embodiment, flexible drill shaft 2206 is a non-rotating shaft havinghigh column strength and comprising a puncturing tip at the distal endof flexible drill shaft 2206. In another embodiment, flexible drillshaft 2206 acts as an ultrasonic drill by connecting the proximal end offlexible drill shaft to an ultrasonic generator. In another embodiment,access catheter 2200 comprises one or more bearings that reduce frictionbetween access catheter 2200 and flexible drill shaft 2206.

FIG. 23D shows a sectional view of an embodiment of a drilling device.Drilling device 2220 comprises a shaft 2222 comprising a proximal rigidportion 2224 and a distal rigid portion 2226. Shaft 2222 may comprise adeformable (e.g., corrugated, plastically deformable, malleable, etc.)portion 2228 between proximal rigid portion 2224 and distal rigidportion 2226. Plastically deformable region 2228 allows the shape ofdrilling device 2220 to be adjusted to facilitate advancement of thedevice through tortous anatomy, to access to a target anatomicallocation and/or to achieve a desired positioning or attitude of the bit2230 within the subject's body. Proximal rigid portion 2224, distalrigid portion 2226 and plastically deformable or malleable region 2228can be made of suitable biocompatible materials such as stainless steele.g. fully annealed stainless steel, copper, aluminum etc. Drillingdevice 2220 further comprises a rotating drill bit 2230 located atdistal end of a rotatable drive member of shaft 2222. Rotating drill bit2230 can be made from suitable materials such as tungsten carbide,carbon steel, diamond powder coated metal etc. Rotating drill bit 2230can be an abrasive coated spherical ball or a twist (e.g., helical)drill bit, masonry drill bit, spur point bit, step drill bit etc.Proximal region of rotating drill bit 2230 is in contact with distal endof shaft 2222. In order to reduce friction between rotating drill bit2230 and shaft 2222, the contact surfaces between rotating drill bit2230 and shaft 2222 comprise a lubricious coating e.g. a Teflon coating.Proximal region of rotating drill bit 2230 is also attached to aflexible drive shaft 2232 that supplies torque to the rotating drill bit2230. In one embodiment, flexible drive shaft 2232 comprises a coilassembly with high torsional stiffness and column strength. In anotherembodiment, flexible drive shaft 2232 comprises a heat treated springsteel cable. Proximal end of flexible drive shaft 2232 is connected to areversible drive motor. In one embodiment, rotating drill bit 2230 andflexible drive shaft 2232 comprise a coaxial lumen to enable drillingdevice 2220 to be introduced over a guidewire into a target anatomy.Such a device can be used for a minimally invasive puncturing ofsuitable anatomical regions for drainage, aeration, introduction ofdiagnostic or therapeutic devices etc. Such a device can also be usedfor enlarging or clearing natural or artificial openings in anatomicalregions. It will be appreciated by those of skill in the art that,although this device 2220 is referred to herein as a “drilling device”it may be used for numerous purposes other than “drilling.” For example,this device 2220 may be used to cut, grind, polish or create grooves ordepressions in bone, cartilage or other tissue and/or may be used as ascrew driver. Thus, in some applications, this drilling device 2220 mayalternatively be aptly referred to as a cutter, grinder, rotating rasp,rotating brush, dremmel, polisher, burnisher, boring tool, groovingtool, etc. Also, in some embodiments, the bit may comprise a drive bitthat is useable to drive a permanent or resorbable bone screw or othertype of screw or anchor. Also, the bit 2230 may be interchangeable and avariety of different bits 2220 may be provided to accomplish variousdifferent applications (e.g., grinding, polishing, burnishing, grooving,boring, rasping, debulking, forming indentations or depressions, drivingscrews, etc.). FIGS. 24A-24C show a sagittal section of an Ethmoid sinusshowing various methods of treating Ethmoid sinus diseases by aminimally invasive approach. FIG. 24A shows a sagittal section of anEthmoid sinus comprising an anterior Ethmoid air cell 2300, a posteriorEthmoid air cell 2302 and an intermediate Ethmoid air cell 2304 locatedbetween anterior Ethmoid air cell 2300 and posterior Ethmoid air cell2302. A guide catheter 2306 is introduced to a region inferior to thebasal lamelia of a middle turbinate. Guide catheter 2306 may comprise adesign selected from the various guide catheter designs disclosed hereinand in the patent documents incorporated herein by reference.Thereafter, an introducer needle 2308 is introduced through guidecatheter 2306. Introducer needle 2308 comprises a lumen through whichdevices such as guidewires can be introduced. Introducer needle 2308 canbe made of suitable biocompatible materials such as Stainless steel,Nitinol, polymers, polymer-metal composites etc. Introducer needle 2308is advanced through guide catheter 2306 such that the distal tip ofintroducer needle 2308 punctures a wall of an Ethmoid air cell e.g.anterior Ethmoid air cell 2300 and enters the Ethmoid air cell.Thereafter, a guidewire 2310 is introduced through introducer needle2308 into the Ethmoid air cell e.g. anterior Ethmoid air cell 2300.Thereafter, introducer needle 2308 is removed from the anatomy. In FIG.24B, a working device is introduced over guidewire 2310 into the Ethmoidair cell. An example of a working device is a balloon catheter 2312comprising a dilating balloon 2314. Thereafter, the working device isused to perform a diagnostic or therapeutic procedure e.g. balloondilation of the introducer needle puncture site to create a drainagechannel for sinus secretions. Similarly, other working devices such asdilating or occluding balloons, dilating stents, suction or irrigationdevices, needles, polypectomy tools, brushes, energy emitting devicessuch as ablation devices, laser devices, image-guided devices containingsensors or transmitters, imaging devices, endoscopes, tissue modifyingdevices such as cutters, biopsy devices, devices for injectingdiagnostic or therapeutic agents, lavage devices, drug delivery devicessuch as substance eluting devices, substance delivery implants etc. maybe used to perform diagnostic or therapeutic procedures. The methodshown in FIGS. 24A-24B may also be used to create an opening of asuitable diameter to facilitate insertion of other working devices intothe Ethmoid air cells. For example, FIG. 24C shows a method of treatingEthmoid sinus diseases by a rongeur. In this method, rongeur 2316 havinga distal cutting tip 2318 is introduced through guide catheter 2306 intoan Ethmoid air cell via the introducer needle puncture site. Thereafter,rongeur 2316 is used to remove tissue from the Ethmoid air cell.

FIGS. 24A′-24A″″ show a method of creating drainage channels for sinussecretions in Ethmoid sinus. In FIG. 24A′, guide catheter 2306 isintroduced to a region inferior to the basal lamella of a middleturbinate. Thereafter, introducer needle 2308 is advanced through guidecatheter 2306 such that the distal tip of introducer needle 2308punctures a wall of an Ethmoid air cell e.g. an intermediate Ethmoid aircell 2304 and enters the Ethmoid air cell. In FIG. 24A″, introducerneedle is used to create internal channels in the Ethmoid sinus bypuncturing walls of adjacent Ethmoid air cells e.g. anterior Ethmoid aircell 2300, posterior Ethmoid air cell 2302 etc. In FIG. 24A′″,introducer needle 2308 and guide catheter 2306 are removed leavingbehind internal channels that allow drainage of sinus secretions throughthe introducer needle puncture site in the intermediate Ethmoid air cell2304. Sinus secretions from anterior Ethmoid air cell 2300 or posteriorEthmoid air cell 2302 flow into intermediate Ethmoid air cell 2304 fromwhich they flow out of the Ethmoid sinus. The internal channels as wellas the introducer needle puncture site in the intermediate Ethmoid aircell 2304 may be dilated using a balloon catheter as shown in FIGS.24A-24B. In FIGS. 24A′-24A′″, introducer needle 2308 was introduced intothe Ethmoid sinus through intermediate Ethmoid air cell 2304. Similarprocedures may be performed by introducing introducer needle 2304 intothe Ethmoid sinus through anterior Ethmoid air cell 2300 or posteriorEthmoid air cell 2302. In one embodiment, anterior Ethmoid air cell2300, posterior Ethmoid air cell 2302 and intermediate Ethmoid air cell2304 are punctured separately through the basal lamella of a middleturbinate to create separate drainage channels for each Ethmoid air cellas shown in FIG. 24A″″.

FIG. 25A shows a perspective view of an embodiment of a microshaver orostium enlarger device 2400. Device 2400 comprises a proximal portion2402 and a distal portion 2403. Proximal portion 2402 is hollow andcomprises a proximal cutting surface 2404 e.g. sharp cutting teeth etc.located on the distal end of proximal portion 2402. Distal portion 2403comprises a distal cutting surface 2406 e.g. sharp cutting teeth etc.located on the proximal end of distal portion 2403. Distal portion 2403is further connected to a pull shaft 2408 that encloses a guidewirelumen 2410. Guidewire lumen 2410 allows microshaver 2400 to beintroduced over a guidewire GW into a target anatomy. The region betweenpull shaft 2408 and proximal portion 2402 encloses a suction lumen 2412.Suction lumen 2412 can be used to remove solid debris or liquids fromthe target anatomy by suction. Proximal portion 2402, distal portion2403 and pull shaft 2408 can be made of suitable biocompatible materialssuch as stainless steel.

FIG. 25B shows a crossection of a paranasal sinus showing one way inwhich the device 2400 of FIG. 25A may be used to remove tissue ormatter. The device 2400 is introduced over a guidewire GW into paranasalsinus 2414. The device 2400 is then positioned such that the tissue ormatter is located between proximal cutting surface 2404 and distalcutting surface 2406. Thereafter, in this embodiment, pull shaft 2408 ispulled in the proximal direction. This causes movement of distal region2403 in the proximal direction with respect to proximal portion 2402.This in turn forces cylindrical distal cutter 2406 to be retracted intothe interior of the cylindrical proximal cutter 2404, thereby cuttingoff or breaking tissue or matter that is captured therebetween.Optionally, in this embodiment, the cylindrical distal cutter 2406cylindrical proximal cutter 2404 may be rotated relative to the other tofurther cut or shave tissue. Also, optionally in this embodiment,suction lumen 2412 can be used to remove any solid debris or liquidsgenerated during the procedure.

FIGS. 25C and 25D show an example of another way in which the device2400 may be used—i.e., to shave tissue or matter. Examples of anatomicalstructures that may be shaved by this device 2400 include bone,cartilage and soft tissues of Eustachian tubes, turbinates, lachrymalducts, anatomical openings such as ostia of paranasal sinuses, ostia oflachrymal ducts, etc. and other regions in the ear, nose, throat ormouth. As shown in FIG. 25C, in this embodiment, there need not be aproximally moveable pull shaft 2408, but rather the distal cuttingsurface 2406 may remain positioned within the cylindrical proximalcutting surface 2404. The cutting surfaces are positioned adjacent tothe tissue or matter to be shaved and the cylindrical distal cutter 2406and/or cylindrical proximal cutter 2404 is/are rotated to shave thetissue or matter. Suction may be applied through lumen 2412 to draw thetissue or matter into slots 2409 such that it will be shaved by therotating proximal cutter 2404.

FIGS. 26A-26C show a device and method for treating a mucocyst of otherflowable substance-containing structure (e.g., cyst, hematoma, pustule,etc.) located within a paranasal sinus, ear, nose or throat. In general,the device comprises an elongate shaft 2500, a penetrator such as aneedle 2502 that is advanceable from and retractable into the shaft 2500to form an opening in the mucocyst or other structure, and a compressorsuch as a balloon 2506 that is useable to compress the mucocyst or otherstructure to force its contents to flow out of the opening created bythe needle 2502 or other penetrator. Specifically, as shown in theexample of FIG. 26A, a guide catheter 2500 is introduced into ananatomical region through an anatomical opening. The outer diameter ofguide catheter 2500 is less than the inner diameter of the anatomicalopening. In FIGS. 26A-26C, frontal sinus FS is used as an example of ananatomical region. Other examples of anatomical regions are otherparanasal sinuses, lachrymal passages, Eustachian tubes and otherstructures in the ear, nose, throat or mouth etc. Guide catheter 2500may comprise a design selected from the various guide catheter designsdisclosed herein and in the patent documents incorporated herein byreference. A puncturing needle 2502 is then introduced through guidecatheter 2500 into the frontal sinus FS. Puncturing needle 2502 has asharp distal tip and can be made from a variety of materials such ashardened tool steel, stainless steel etc. Puncturing needle 2502 isnavigated through the frontal sinus FS such that the distal tip ofpuncturing needle 2502 punctures a mucocyst 2503 in the frontal sinusFS. Thereafter, puncturing needle 2502 is withdrawn. In FIG. 26B, aguidewire GW is introduced into the frontal sinus FS. Thereafter, aballoon catheter 2504 comprising a balloon 2506 is introduced overguidewire GW into the frontal sinus ES. Balloon 2506 can be made ofsuitable compliant or semi-compliant materials such as crosslinkedpolyethylene or other polyolefins, polyurethane, flexiblepolyvinylchloride, Nylon, etc. Balloon 2506 is then inflated. Inflatedballoon 2506 compresses the punctured mucocyst 2503. This causesdrainage of mucocyst secretions into the frontal sinus FS. In FIG. 26C,balloon 2506 is inflated further so that it occupies a volume in thefrontal sinus FS and displaces the mucocyst secretions from the frontalsinus FS out through the frontal sinus ostium FSO.

FIGS. 27A-27B show various steps of a method of treating a mucocyst by aballoon catheter comprising a deployable puncturing needle. In FIG. 27A,a guide catheter 2600 is introduced into an anatomical region through ananatomical opening. The outer diameter of guide catheter 2600 is lessthan the inner diameter of the anatomical opening. In FIGS. 27A-27B,frontal sinus FS is used as an example of an anatomical region. Otherexamples of anatomical regions are other paranasal sinuses, lachrymalpassages, Eustachian tubes, other ear, nose, throat and mouth structuresetc. Guide catheter 2600 may comprise a design selected from the variousguide catheter designs disclosed herein and in the patent documentsincorporated herein by reference. A balloon catheter 2602 comprising aballoon 2604 and a deployable puncturing needle 2606 is then introducedthrough guide catheter 2600 into the frontal sinus FS. Balloon 2604 canbe made of suitable compliant or semi-compliant materials such ascrosslinked polyethylene or other polyolefins, polyurethane, flexiblepolyvinylchloride, Nylon, etc. Deployable puncturing needle 2606 can bemade from a variety of materials such as hardened tool steel, stainlesssteel etc. Balloon catheter 2604 is oriented in a desired orientationand deployable puncturing needle 2606 is advanced such that the distaltip of deployable puncturing needle 2606 punctures the mucocyst MC.Thereafter, deployable puncturing needle 2606 is withdrawn into ballooncatheter 2602. In FIG. 27B, balloon 2604 is inflated. Inflated balloon2604 compresses the punctured mucocyst MC. This causes drainage ofmucocyst secretions into the frontal sinus FS. Balloon 2604 is theninflated further so that it occupies a volume in the frontal sinus FSand displaces the mucocyst secretions from the frontal sinus FS outthrough the frontal sinus ostium FSO. In one embodiment, deployablepuncturing needle 2606 is located in a needle lumen. Deployablepuncturing needle 2606 may be advanced or withdrawn by advancing orwithdrawing deployable puncturing needle 2606 through the needle lumen.

FIGS. 28A-28C show various embodiments of catheters comprising agentdelivery needles. In FIG. 28A, catheter 2700 comprises a shaft 2702having a guidewire lumen. Catheter 2700 further comprises a deployableinjecting needle 2704 made from suitable biocompatible materials such asstainless steel. Deployable injecting needle 2704 comprises a lumen forinjecting one or more diagnostic or therapeutic agents 2706 into theadjacent anatomy. Deployable injecting needle 2704 is deployed at anysuitable angle to the longitudinal axis of shaft 2702, for example suchangle may range from 0 degrees to 135 degrees. In one embodiment,deployable injecting needle 2704 is located in a needle lumen.Deployable injecting needle 2704 is deployed or withdrawn by relativemotion of deployable injecting needle 2704 with respect to shaft 2702.In another embodiment, deployable injecting needle 2704 can be deployedor withdrawn by inflating or deflating a deploying balloon. Thedeploying balloon can be made from suitable materials such as polyimide,parylene (e.g. C, D, N), silicone, polyurethane, polyethyleneterephthalate etc. Catheter 2700 is introduced into a target anatomy anddeployable injecting needle 2704 is deployed. Deployable injectingneedle 2704 penetrates into the adjacent anatomy. One or more diagnosticor therapeutic agents 2706 are then injected into the adjacent anatomy.In one embodiment, catheter 2700 may be introduced in an anatomicalregion through a guide catheter 2708. FIG. 28B shows a perspective viewof catheter 2700 of FIG. 28A wherein catheter 2700 further comprises asecond deployable injecting needle 2710. Second deployable injectingneedle 2710 comprises a lumen for injecting one or more diagnostic ortherapeutic agents 2712 into the adjacent anatomy. In one embodiment,diagnostic or therapeutic agents 2712 are the same as diagnostic ortherapeutic agents 2706. FIG. 28C shows a perspective view of catheter2700 of FIG. 28A wherein catheter 2700 further comprises a balloon 2714.In one embodiment, balloon 2714 is a dilating balloon made of suitablenon-compliant materials e.g. polyethylene terephthalate etc. Thisembodiment can be used for both balloon dilation and agent delivery. Inanother embodiment, balloon 2714 is an anchoring balloon made ofsuitable non-compliant materials e.g. polyethylene terephthalate etc. orsuitable compliant or semi-compliant materials such as crosslinkedpolyethylene or other polyolefins, polyurethane, flexiblepolyvinylchloride, Nylon etc. The anchoring balloon can be used tostabilize the position and orientation of catheter 2700 before agentdelivery.

Examples of diagnostic or therapeutic agents that can be delivered bythe catheters in FIGS. 28A-28C are pharmaceutically acceptable salt ordosage form of an antimicrobial agent (e.g., antibiotic, antiviral,anti-parasitic, antifungal, etc.), an anesthetic agent with or without avasoconstriction agents (e.g. Xylocaine with or without Epinephrine,Tetracaine with or without epinephrine, etc.), an analgesic agent, acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen oranother substance that causes secretion of mucous by tissues, hemostaticagents to stop bleeding, anti-proliferative agents, cytotoxic agentse.g. alcohol, biological agents such as protein molecules, stem cells,genes or gene therapy preparations, viral vectors carrying DNA, proteinsor mRNA coding for important therapeutic functions or substances etc.Catheters in FIGS. 28A-28C can be used to diagnose or treat anatomicalregions such as paranasal sinuses, regions in the Eustachian tubes,lachrymal ducts, ducts of salivary glands, anatomical openings such asostia of paranasal sinuses, ostia of lachrymal ducts, other regions inthe ear, nose, throat or mouth etc.

FIG. 29A illustrates an embodiment of a displacement catheter todisplace and remove secretions in an anatomical region. Displacementcatheter 2800 comprises an outer sheath 2802 that encloses a ballooncatheter 2804. Outer sheath 2802 may be flexible or substantially rigid.Outer sheath 2802 may be made of suitable materials such as Pebax, HDPEetc. Outer sheath 2802 may comprise a hypotube made of suitablebiocompatible materials such as stainless steel, Nitinol etc. Ballooncatheter 2804 comprises a catheter shaft 2806 and a balloon 2808 locatedon the distal region of catheter shaft 2806. Catheter shaft 2806 may bemade of suitable materials such as Pebax, HDPE etc. Balloon 2808 may bemade from suitable compliant or semi-compliant material such ascrosslinked polyethylene or other polyolefins, polyurethane, flexiblepolyvinylchloride, Nylon etc.

FIG. 29B shows a sectional view of an anatomical region showing a methodof displacing secretions by the displacement catheter of FIG. 29A.Displacement catheter 2800 is introduced in an anatomical region. InFIG. 29B, a Maxillary sinus MS is used as an example of an anatomicalregion. Other examples of anatomical regions that can be treated usingdisplacement catheter 2800 are other paranasal sinuses, lachrymalpassages, Eustachian tubes etc. Displacement catheter 2800 can beadvanced into an anatomical region through natural openings e.g. ostiaof sinuses or artificially created openings. In this example,displacement catheter 2800 is advanced into the Maxillary sinus througha natural opening such as a maxillary sinus ostium MSO such that thedistal end of displacement catheter is near the distal region ofMaxillary sinus MS. Outer diameter of outer sheath 2802 is less thaninner diameter of Maxillary sinus ostium MSO. Thereafter, outer sheath2802 is withdrawn gradually by pulling outer sheath 2802 in the proximaldirection over balloon catheter 2804. Simultaneously, balloon 2808 isinflated by a suitable inflating medium such as saline mixed withradiographic contrast. This causes distal region of balloon 2804 toinflate before the proximal region of balloon 2804. Balloon 2804gradually begins to occupy available volume in the Maxillary sinus MSand thus displaces secretions 2810 out of the Maxillary sinus MS throughthe Maxillary sinus ostium MSO. In one embodiment of balloon 2804,distal region of balloon 2804 has a higher compliance than proximalregions of balloon 2804. In another embodiment, balloon 2804 comprisesmultiple compartments such that each compartment can be inflatedindependently of other compartments. Balloon 2804 may be detachablyconnected to catheter shaft 2806 to enable permanent occlusion of theanatomical region. Balloon 2804 may also comprise a variety of drugdelivery mechanisms including drug eluting coatings, drug eluting poresfor eluting a drug dissolved in the inflating medium etc.

FIG. 30 shows a perspective view of an embodiment of an ultrasonicdrilling device. Drilling device 2900 comprises a rigid or flexibledrilling shaft 2902. Drilling shaft 2902 can be made of suitablematerials such as tungsten carbide flexible wire. The proximal end ofdrilling shaft 2902 is connected to a piezoelectric crystal 2904 such asa quartz (SiO2) or barium titanate (BaTiO3) crystal. Piezoelectriccrystal 2904 may have a layer of backing material 2906 on the proximalsurface of piezoelectric crystal 2904. Piezoelectric crystal 2904 isconnected by electrodes 2908 to an electric power source 2910. Electricpower source 2910 delivers a suitable current via electrodes 2908 topiezoelectric crystal 2904 to cause piezoelectric crystal 2904 tovibrate at an ultrasonic frequency. The vibration of piezoelectriccrystal 2904 is transmitted to drilling shaft 2902. In one embodiment,drilling shaft 2902 is connected to piezoelectric crystal 2904 by acoupler 2912.

FIGS. 30A-30B show a sectional view of an anatomical region showing amethod of enlarging a natural or artificially created anatomical openingusing the drilling device of FIG. 30. The drilling device may also beused to create new openings in an anatomical region. Distal part ofdrilling device 2900 comprising drilling shaft 2902 of diameter D.sub.2is positioned such that the distal end of drilling shaft 2902 touches ananatomical opening e.g. a sphenoid sinus ostium SSO to be dilated. Theanatomical opening has an initial diameter D.sub.1. Thereafter, currentfrom electric power source 2910 is switched on, which in turn causesdrilling shaft 2902 to vibrate in the axial direction. The vibration ofdrilling shaft 2902 causes distal tip of drilling shaft 2902 to impactthe anatomical opening. In FIG. 30B, the impact of drilling shaft 2902causes dilation of the anatomical opening from an initial diameterD.sub.1 to a diameter D.sub.2.

Similarly, other embodiments of drilling devices may be used topuncture, remodel or change the shape, size or configuration ofanatomical structures such as paranasal sinuses, Eustachian tubes,middle ear, nasopharynx, Lachrymal ducts or other anatomical regions inthe ear, nose, throat or mouth. Such drilling devices may comprise forexample elements for ablation or delivery of energy such as laser, RF,thermal shock waves etc.

FIG. 31 shows a sectional view of an embodiment of a catheter forproviding an internal cast for fractured bony cavities. Catheter 3000comprises a shaft 3002 comprising a plurality of inflating elements e.g.inflating balloon in the distal region of shaft 3002. In the exampleshown in FIG. 31, catheter 3000 comprises a proximal interior balloon3004, a distal interior balloon 3006 and an intermediate interiorballoon 3008 located between proximal interior balloon 3004 and distalinterior balloon 3006. Catheter 3000 further comprises an intermediateballoon 3010 covering proximal interior balloon 3004 and intermediateinterior balloon 3008 as shown in FIG. 31. Catheter 3000 furthercomprises an outer balloon 3012 that covers intermediate balloon 3010and a portion of distal interior balloon 3006 as shown in FIG. 31. Theballoons on catheter 3000 can be inflated independently of each other.For example proximal interior balloon 3004 can be inflated by a proximalinterior balloon lumen 3014, distal interior balloon 3006 can beinflated by a distal interior balloon inflation lumen 3016 andintermediate interior balloon 3008 can be inflated by an intermediateballoon inflation lumen 3018. The balloons on catheter 3000 may be madefrom suitable compliant or semi-compliant material such as crosslinkedpolyethylene or other polyolefins, polyurethane, flexiblepolyvinylchloride, Nylon etc. or from suitable non-compliant materialse.g. polyethylene terephthalate etc. The balloons on catheter 3000 maybe coated with a variety of coatings including lubricious coatings, drugeluting coatings etc. FIG. 31A shows a crossection through the outerballoon 3012 in the catheter 3000 of FIG. 31 through plane 31A-31A.Outer balloon 3012 comprises a balloon material 3020 made from suitablecompliant or semi-compliant material such as crosslinked polyethylene orother polyolefins, polyurethane, flexible polyvinylchloride, Nylon etc.or from suitable non-compliant materials e.g. polyethylene terephthalateetc. A coating 3022 is located on the outer surface of balloon material3020. Examples of materials that can be used in coating 3022 arecontrast agents, pharmaceutically acceptable salt or dosage form of anantimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic,antifungal, etc.), an anesthetic agent with or without avasoconstriction agents (e.g. Xylocaine with or without Epinephrine,Tetracaine with or without epinephrine, etc.), an analgesic agent, acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen oranother substance that causes secretion of mucous by tissues, hemostaticagents to stop bleeding, anti-proliferative agents, cytotoxic agentse.g. alcohol, biological agents such as protein molecules, stem cells,genes or gene therapy preparations etc.

FIGS. 31B-31D shows various steps of a method of providing an internalcast for a fractured bony cavity using the catheter shown in FIG. 31. InFIGS. 31B-31D, Maxillary sinus MS is used as an example of bony cavitythat can be treated using catheter 3000. FIG. 31B shows a patient with afractured bony cavity e.g. a fractured Maxillary sinus MS having one ormore fractured bones 3024. In FIG. 31C, catheter 3000 is introduced intothe Maxillary sinus MS through a natural opening e.g. an ostium or anartificially created opening. In FIG. 31D, one or more balloons oncatheter 3000 are sequentially inflated to push fractured bones 3024into their original un-fractured configuration. Catheter 3000 may thenbe left in place for a desired period ranging from a few minutes toseveral days during which fractured bones 3024 begin to heal in theiroriginal un-fractured configuration. After catheter 3000 has been leftin place for the desired period, catheter 3000 is removed by deflatingthe balloons and withdrawing catheter 3000 from the anatomy. Thus,catheter 3000 provides an internal cast for a fractured bony cavity.Various embodiments of catheter 3000 may be used for crating internalcasts for fractured paranasal sinuses, lachrymal passages, Eustachiantubes, other structures in the ear, nose, throat, mouth etc.

The various devices and methods disclosed herein may be used inconjunction with various surgical navigations systems. FIGS. 32 and 32Ashow an embodiment of a surgical navigation system comprisingelectromagnetic sensors. Examples of electromagnetic sensors that can beused with the present invention are electromagnetic sensors of anelectromagnetic surgical navigation system such as GE InstaTrak™ 3500plus system etc. FIG. 32 shows a perspective view of a patient's headshowing the location of external ear canal electromagnetic sensors 3100and teeth electromagnetic sensors 3102. External ear canalelectromagnetic sensors 3100 are introduced through an ear canal into aregion adjacent to a tympanum. Teeth electromagnetic sensors 3102 areattached to one or more teeth of the patient. In one embodiment, teethelectromagnetic sensors 3102 are attached to teeth using an adhesive. Inan alternate embodiment, teeth electromagnetic sensors 3102 are attachedto braces or caps which in turn are attached to teeth. The braces orcaps can be made of suitable materials that cause minimal artifacts onCT or MRI images. An example of such a material is aluminum alloy2017-T4 which causes minimal artifacts on a CT scan image. Otherlocations of electromagnetic sensors include skin (e.g. a skin patchcomprising an electromagnetic sensor), a head frame etc. The patient'shead is imaged using an imaging modality such as CT or MRI. External earcanal electromagnetic sensors 3100 and teeth electromagnetic sensors3102 are passively imaged by the imaging modality and thus act asfiducial markers.

FIGS. 32 and 32A illustrate a surgical navigation system comprisingfiducial markers that have electromagnetic sensors. Various otherembodiments of fiducial markers such as passively imaged fiducialmarkers or active sensors or transmitters may be used in conjunctionwith the various methods and devices disclosed herein. The fiducialmarkers may be located on relevant anatomical regions such as teeth, earcanals, skull bones, frames fixed to rigid bones etc. The fiducialmarkers may be used with a variety of modalities including but notlimited to electromagnetic, infrared, ultrasonic, radio-frequency, MRI,CT, Fluoroscopic or other 2D or 3D image guided systems for the head,neck or other anatomical regions manufactured by companies such asBiosense, Stryker, Brainlab, Xomed, GE/VTI etc.

FIG. 32A shows an enlarged view of region 32A in FIG. 32. Teethelectromagnetic sensors 3102 are connected to the electromagneticsurgical navigation system by removable leads 3104. In anotherembodiment, external ear canal electromagnetic sensors 3100 or teethelectromagnetic sensors 3102 are connected to the electromagneticsurgical navigation system by telemetry. During a procedure, externalear canal electromagnetic sensors 3100 and/or teeth electromagneticsensors 3102 are actively imaged by suitable electromagnetic surgicalnavigation systems such as GE Instatrak™ 3500 plus system etc.Thereafter, data from imaging modality such as CT or MRI and theelectromagnetic surgical navigation system is merged to obtain a threedimensional map of the anatomy showing the electromagnetic sensors. Thethree dimensional map can then be used for image guided procedures suchas diagnostic or therapeutic procedures of paranasal sinuses, Eustachiantubes, lachrymal ducts, other ear, nose, throat or mouth structures etc.

Other image guided surgery systems such as infrared sensor based systemse.g. Stryker Leibinger® Navigation System can also be used inconjunction with one or more methods or devices disclosed herein.

FIG. 33 shows a section of the anatomical region around a Eustachiantube (ET) showing a diagnostic or therapeutic procedure being performedby devices inserted through the pharyngeal ostium of the Eustachiantube. FIG. 33 shows a guidewire GW inserted into a desired region in theET through the Nasopharynx and a diagnostic or therapeutic beingperformed by a device introduced into the Eustachian tube over guidewireGW.

FIG. 33A shows an enlarged view of region 33A in FIG. 33 showing theanatomical region around a Eustachian tube (ET) showing a diagnostic ortherapeutic procedure being performed by devices inserted through thepharyngeal ostium of the Eustachian tube. In one embodiment, guidewireGW comprises an anchoring balloon 3200 located on the distal region ofguidewire GW. Anchoring balloon 3200 is inflated after positioningguidewire GW at a target location. Anchoring balloon 3200 anchorsguidewire GW to the adjacent anatomy and prevents accidentalrepositioning of guidewire GW during a diagnostic or therapeuticprocedure. Anchoring balloon 3200 may be made from suitable compliant orsemi-compliant material such as crosslinked polyethylene or otherpolyolefins, polyurethane, flexible polyvinylchloride, Nylon etc.Guidewire GW may comprise anchoring elements other than anchoringballoon 3200 such as a notch on guidewire GW, a bent region on guidewireGW, a self expanding element, a hook, a coiled element etc. In anotherembodiment, guidewire GW comprises a sensor 3202 located on the distalregion of guidewire GW. Sensor 3202 enables guidewire GW to be used inconjunction with a suitable surgical navigation system. In oneembodiment, sensor 3202 is an electromagnetic sensor used in conjunctionwith an electromagnetic surgical navigation system such as GE InstaTrak™3500 plus system etc. One or more sensor 3202 or other types of surgicalnavigation sensors or transmitters may also be located on otherdiagnostic or therapeutic devices disclosed herein. Sensor 3202 may beused in conjunction with a stationary sensor 3204 located in theexternal ear. The combination of sensor 3202 and stationary sensor 3204enables guidewire GW to be accurately positioned in a target region. Inan embodiment, a radioopaque plug 3206 is inserted from the external earto a region adjacent to an eardrum. Radioopaque plug 3206 serves as afiducial marker during preoperative scanning of the patient and thusenables a physician to accurately position a diagnostic or therapeuticdevice close to the eardrum. Other image guidance methods and devicescan also be used in conjunction with diagnostic or therapeuticprocedures disclosed herein. FIG. 33A also shows a diagnostic ortherapeutic device 3208 comprising a shaft 3210 and a working element3212 e.g. a dilating balloon being introduced over guidewire GW.Diagnostic or therapeutic device 3208 may comprise a radiopaque marker3214.

FIG. 33B shows a front view of a human head with a portion of the faceremoved to show an embodiment of a method of introducing a guidewireinto a Eustachian tube. In FIG. 33B, a guide catheter 3250 is introducedthrough a nostril into the Nasopharynx. Distal portion of guide catheter3250 may comprise a bent or angled region. For example, such bent orangled region may form e an internal angle ranging from 45 degrees to150 degrees. Guide catheter 3250 can be constructed using one of thevarious designs disclosed herein and in the patent documentsincorporated herein by reference. Guide catheter 3250 is positioned inthe Nasopharynx such that the distal tip of guide catheter 3250 islocated near a nasopharyngeal opening of a Eustachian tube. Thereafter,a guidewire GW is introduced through guide catheter 3250 into theEustachian tube. Guidewire GW can then be used to advance one or morediagnostic or therapeutic devices into the Eustachian tube to performone or more diagnostic or therapeutic procedures.

FIGS. 34A-34D illustrate various examples of working elements that canbe located on the diagnostic or therapeutic device in FIG. 33. FIG. 34Ashows an example of a working element comprising a dilating balloon.Dilating balloon 3312 can be made from a suitable non-compliantmaterials e.g. polyethylene terephthalate, Nylon etc. Similarly, devicesshown in FIGS. 14, 15, 16, 17 and 18 may also be used to treat aEustachian tube as shown in FIG. 33.

FIG. 34B shows an example of a working element comprising a dilatingballoon loaded with a balloon-expandable stent. Dilating balloon 3314can be made from a suitable non-compliant materials e.g. polyethyleneterephthalate, Nylon etc. Several types of stent designs can be used toconstruct stent 3316 such as metallic tube designs, polymeric tubedesigns, chain-linked designs, spiral designs, rolled sheet designs,single wire designs etc. These designs may have an open celled or closedcelled structure. A variety of fabrication methods can be used forfabricating stent 3316 including but not limited to laser cutting ametal or polymer element, welding metal elements etc. A variety ofmaterials can be used for fabricating stent 3316 including but notlimited to metals, polymers, foam type materials, plastically deformablematerials, super elastic materials etc. A variety of features can beadded to stent 3316 including but not limited to radiopaque coatings,drug elution mechanisms to elute anti-inflammatory agents, antibioticsetc. In one embodiment, stent 3316 is bioabsorbable. Working elementsmay also comprise a self-expanding stent instead of apressure-expandable stent.

FIG. 34C shows an example of a working element comprising a lavageelement. Lavage element 3318 comprises a plurality of lavage openings3320. Lavage openings are connected to a lavage lumen in shaft 3210through which suitable lavage media such as solutions containingcontrast agents, pharmaceutically acceptable salt or dosage form of anantimicrobial agent (e.g., antibiotic, antiviral, anti-parasitic,antifungal, etc.), an anesthetic agent with or without avasoconstriction agents (e.g. Xylocaine with or without Epinephrine,Tetracaine with or without epinephrine, etc.), an analgesic agent, acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), an allergen oranother substance that causes secretion of mucous by tissues, hemostaticagents to stop bleeding, anti-proliferative agents, cytotoxic agentse.g. alcohol, biological agents such as protein molecules, stem cells,genes or gene therapy preparations etc. can be delivered. In oneembodiment, a fraction of lavage openings 3320 are connected to anaspiration lumen to aspirate the lavage media out of the Eustachiantube.

FIG. 34D shows an example of a working element comprising a substancedelivery reservoir. Substance delivery reservoir 3322 may be fully orpartially biodegradable or non-biodegradable. In one embodiment,substance delivery reservoir 3322 is made of a suitable biocompatiblematerial such as hydrogel (e.g. collage hydrogel). In anotherembodiment, substance delivery reservoir 3322 comprises a porous matrixformed of a porous material such as a flexible or rigid polymer foam,cotton wadding, gauze, etc. Examples of biodegradable polymers that maybe foamed or otherwise rendered porous include polyglycolide,poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone,polycaprolactone, polygluconate, polylactic acid-polyethylene oxidecopolymers, modified cellulose, collagen, polyorthoesters,polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxyacid) and combinations thereof. Examples of non-biodegradable polymersthat may be foamed or otherwise rendered porous include polyurethane,polycarbonate, silicone elastomers etc. Substance delivery reservoir3322 may also include one or more embodiments disclosed in U.S. patentapplication Ser. No. 10/912,578 entitled “Implantable Device and Methodsfor Delivering Drugs and Other Substances to Treat Sinusitis and OtherDisorders” filed on Aug. 4, 2004, the entire disclosure of which isexpressly incorporated herein by reference. The substance deliveryreservoir 3322 or any substance delivery devices described in thisapplication may be used to deliver various types of therapeutic ordiagnostic agents. The term “diagnostic or therapeutic substance” asused herein is to be broadly construed to include any feasible drugs,prodrugs, proteins, gene therapy preparations, cells, diagnostic agents,contrast or imaging agents, biologicals, etc. Such substances may be inbound or free form, liquid or solid, colloid or other suspension,solution or may be in the form of a gas or other fluid or nan-fluid. Forexample, in some applications where it is desired to treat or prevent amicrobial infection, the substance delivered may comprisepharmaceutically acceptable salt or dosage form of an antimicrobialagent (e.g., antibiotic, antiviral, antiparacytic, antifungal, etc.), acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), etc.

Some nonlimiting examples of antimicrobial agents that may be used inthis invention include acyclovir, amantadine, aminoglycosides (e.g.,amikacin, gentamicin and tobramycin), amoxicillin,amoxicillin/clavulanate, amphotericin B, ampicillin,ampicillin/sulbactam, atovaquone, azithromycin, cefazolin, cefepime,cefotaxime, cefotetan, cefpodoxime, ceftazidime, ceftizoxime,ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol,clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone,dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet,ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazole,ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin,penicillin G, pentamidine, piperacillin/tazobactam, rifampin,quinupristin-dalfopristin, ticarcillin/clavulanate,trimethoprim/sulfamethoxazole, valcyclovir, vancomycin, mafenide, silversulfadiazine, mupirocin (e.g., Bactroban Nasal®, Glaxo SmithKline,Research Triangle Park, N.C.), nystatin, triamcinolonelnystatin,clotrimazole/betamethasone, clotrimazole, ketoconazole, butoconazole,miconazole, tioconazole, detergent-like chemicals that disrupt ordisable microbes (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride,menfegol, and N-docasanol); chemicals that block microbial attachment totarget cells and/or inhibits entry of infectious pathogens (e.g.,sulphated and sulponated polymers such as PC-515 (carrageenan),Pro-2000, and Dextrin 2 Sulphate); antiretroviral agents (e.g., PMPAgel) that prevent retroviruses from replicating in the cells;genetically engineered or naturally occurring antibodies that combatpathogens such as anti-viral antibodies genetically engineered fromplants known as “plantibodies;” agents which change the condition of thetissue to make it hostile to the pathogen (such as substances whichalter mucosal pH (e.g., Buffer Gel and Acidform); non-pathogenic or“friendly” microbes that cause the production of hydrogen peroxide orother substances that kill or inhibit the growth of pathogenic microbes(e.g., lactobacillus); antimicrobial proteins or peptides such as thosedescribed in U.S. Pat. No. 6,716,813 (Lin et al.,) which is expresslyincorporated herein by reference or antimicrobial metals (e.g.,colloidal silver).

Additionally or alternatively, in some applications where it is desiredto treat or prevent inflammation the substances delivered in thisinvention may include various steroids or other anti-inflammatory agents(e.g., nonsteroidal anti-inflammatory agents or NSAIDS), analgesicagents or antipyretic agents. For example, corticosteroids that havepreviously administered by intranasal administration may be used, suchas beclomethasone (Vancenase® or Beconase®), flunisolide (Nasalide®),fluticasone proprionate (Flonase®), triamcinolone acetonide (Nasacort®),budesonide (Rhinocort Aqua®), loterednol etabonate (Locort) andmometasone (Nasonex®). Other salt forms of the aforementionedcorticosteroids may also be used. Also, other non-limiting examples ofsteroids that may be useable in the present invention include but arenot limited to aclometasone, desonide, hydrocortisone, betamethasone,clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone,prednicarbate; amcinonide, desoximetasone, diflorasone, fluocinolone,fluocinonide, halcinonide, clobetasol, augmented betamethasone,diflorasone, halobetasol, prednisone, dexamethasone andmethylprednisolone. Other anti-inflammatory, analgesic or antipyreticagents that may be used include the nonselective COX inhibitors (e.g.,salicylic acid derivatives, aspirin, sodium salicylate, cholinemagnesium trisalicylate, salsalate, diflunisal, sulfasalazine andolsalazine; para-aminophenol derivatives such as acetaminophen; indoleand indene acetic acids such as indomethacin and sulindac; heteroarylacetic acids such as tolmetin, dicofenac and ketorolac; arylpropionicacids such as ibuprofen, naproxen, flurbiprofen, ketoprofen, fenoprofenand oxaprozin; anthranilic acids (fenamates) such as mefenamic acid andmeloxicam; enolic acids such as the oxicams (piroxicam, meloxicam) andalkanones such as nabumetone) and Selective COX-2 Inhibitors (e.g.,diaryl-substituted furanones such as rofecoxib; diaryl-substitutedpyrazoles such as celecoxib; indole acetic acids such as etodolac andsulfonanilides such as nimesulide)

Additionally or alternatively, in some applications, such as those whereit is desired to treat or prevent an allergic or immune response and/orcellular proliferation, the substances delivered in this invention mayinclude a) various cytokine inhibitors such as humanized anti-cytokineantibodies, anti-cytokine receptor antibodies, recombinant (new cellresulting from genetic recombination) antagonists, or soluble receptors;b) various leucotriene modifiers such as zafirlukast, montelukast andzileuton; c) immunoglobulin E (IgE) inhibitors such as Omalizumab (ananti-IgE monoclonal antibody formerly called rhu Mab-E25) and secretoryleukocyte protease inhibitor) and d) SYK Kinase inhibitors such as anagent designated as “R-112” manufactured by Rigel Pharmaceuticals, Inc,or South San Francisco, Calif.

Additionally or alternatively, in some applications, such as those whereit is desired to shrink mucosal tissue, cause decongestion or effecthemostasis, the substances delivered in this invention may includevarious vasoconstrictors for decongestant and or hemostatic purposesincluding but not limited to pseudoephedrine, xylometazoline,oxymetazoline, phenylephrine, epinephrine, etc.

Additionally or alternatively, in some applications, such as those whereit is desired to facilitate the flow of mucous, the substances deliveredin this invention may include various mucolytics or other agents thatmodify the viscosity or consistency of mucous or mucoid secretions,including but not limited to acetylcysteine (MUCOMyst™, Mucosil™) andguaifenesin.

In one particular embodiment, the substance delivered by this inventioncomprises a combination of an anti-inflammatory agent (e.g. a steroid oran NSAID) and a mucolytic agent.

Additionally or alternatively, in some applications such as those whereit is desired to prevent or deter histamine release, the substancesdelivered in this invention may include various mast cell stabilizers ordrugs which prevent the release of histamine such as cromolyn (e.g.,Nasal Chrom®) and nedocromil.

Additionally or alternatively, in some applications such as those whereit is desired to prevent or inhibit the effect of histamine, thesubstances delivered in this invention may include variousantihistamines such as azelastine (e.g., Astylin®), diphenhydramine,loratidine, etc.

Additionally or alternatively, in some embodiments such as those whereit is desired to dissolve, degrade, cut, break or remodel bone orcartilage, the substances delivered in this invention may includesubstances that weaken or modify bone and/or cartilage to facilitateother procedures of this invention wherein bone or cartilage isremodeled, reshaped, broken or removed. One example of such an agentwould be a calcium chelator such as EDTA that could be injected ordelivered in a substance delivery implant next to a region of bone thatis to be remodeled or modified. Another example would be a preparationconsisting of or containing bone degrading cells such as osteoclasts.Other examples would include various enzymes of material that may softenor break down components of bone or cartilage such as collagenase (CGN),trypsin, trypsin/EDTA, hyaluronidase, and tosyllysylchloromethane(TLCM).

Additionally or alternatively, in some applications, the substancesdelivered in this invention may include other classes of substances thatare used to treat rhinitis, nasal polyps, nasal inflammation, and otherdisorders of the ear, nose and throat including but not limited toanti-cholinergic agents that tend to dry up nasal secretions such asipratropium (Atrovent Nasal®), as well as other agents not listed here.

Additionally or alternatively, in some applications such as those whereit is desired to draw fluid from polyps or edematous tissue, thesubstances delivered in this invention may include locally or topicallyacting diuretics such as furosemide and/or hyperosmolar agents such assodium chloride gel or other salt preparations that draw water fromtissue or substances that directly or indirectly change the osmolarcontent of the mucous to cause more water to exit the tissue to shrinkthe polyps directly at their site.

Additionally or alternatively, in some applications such as thosewherein it is desired to treat a tumor or cancerous lesion, thesubstances delivered in this invention may include antitumor agents(e.g., cancer chemotherapeutic agents, biological response modifiers,vascularization inhibitors, hormone receptor blockers, cryotherapeuticagents or other agents that destroy or inhibit neoplasia ortumorigenesis) such as; alkylating agents or other agents which directlykill cancer cells by attacking their DNA (e.g., cyclophosphamide,isophosphamide), nitrosoureas or other agents which kill cancer cells byinhibiting changes necessary for cellular DNA repair (e.g., carmustine(BCNU) and lomustine (CCNU)), antimetabolites and other agents thatblock cancer cell growth by interfering with certain cell functions,usually DNA synthesis (e.g., 6 mercaptopurine and 5-fluorouracil (5FU),antitumor antibiotics and other compounds that act by binding orintercalating DNA and preventing RNA synthesis (e.g., doxorubicin,daunorubicin, epirubicin, idarubicin, mitomycin-C and bleomycin) plant(vinca) alkaloids and other anti-tumor agents derived from plants (e.g.,vincristine and vinblastine), steroid hormones, hormone inhibitors,hormone receptor antagonists and other agents which affect the growth ofhormone-responsive cancers (e.g., tamoxifen, herceptin, aromataseingibitors such as aminoglutethamide and formestane, trriazoleinhibitors such as letrozole and anastrazole, steroidal inhibitors suchas exemestane), antiangiogenic proteins, small molecules, gene therapiesand/or other agents that inhibit angiogenesis or vascularization oftumors (e.g., meth-1, meth-2, thalidomide), bevacizumab (Avastin),squalamine, endostatin, angiostatin, Angiozyme, AE-941 (Neovastat),CC-5013 (Revimid), medi-522 (Vitaxin), 2-methoxyestradiol (2ME2,Panzem), carboxyamidotriazole (CAI), combretastatin A4 prodrug (CA4P),SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11, IM862,TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon alpha,interleukin-12 (IL-12) or any of the compounds identified in ScienceVol. 289, Pages 1197-1201 (Aug. 17, 2000) which is expresslyincorporated herein by reference, biological response modifiers (e.g.,interferon, bacillus calmette-guerin (BCG), monoclonal antibodies,interluken 2, granulocyte colony stimulating factor (GCSF), etc.), PGDFreceptor antagonists, herceptin, asparaginase, busulphan, carboplatin,cisplatin, carmustine, cchlorambucil, cytarabine, dacarbazine,etoposide, flucarbazine, fluorouracil, gemcitabine, hydroxyurea,ifosphamide, irinotecan, lomustine, melphalan, mercaptopurine,methotrexate, thioguanine, thiotepa, tomudex, topotecan, treosulfan,vinblastine, vincristine, mitoazitrone, oxaliplatin, procarbazine,streptocin, taxol, taxotere, analogs/congeners and derivatives of suchcompounds as well as other antitumor agents not listed here.

Additionally or alternatively, in some applications such as those whereit is desired to grow new cells or to modify existing cells, thesubstances delivered in this invention may include cells (mucosal cells,fibroblasts, stem cells or genetically engineered cells) as well asgenes and gene delivery vehicles like plasmids, adenoviral vectors ornaked DNA, mRNA, etc. injected with genes that code foranti-inflammatory substances, etc., and, as mentioned above, osteoclaststhat modify or soften bone when so desired, cells that participate in oreffect mucogenesis or ciliagenesis, etc.

Additionally or alternatively to being combined with a device and/or asubstance releasing modality, it may be ideal to position the device ina specific location upstream in the mucous flow path (i.e. frontal sinusor ethmoid cells). This could allow the deposition of fewer drugreleasing devices, and permit the “bathing” of all the downstreamtissues with the desired drug. This utilization of mucous as a carrierfor the drug may be ideal, especially since the concentrations for thedrug may be highest in regions where the mucous is retained; whereasnon-diseased regions with good mucous flow will be less affected by thedrug. This could be particularly useful in chronic sinusitis, or tumorswhere bringing the concentration of drug higher at those specific sitesmay have greater therapeutic benefit. In all such cases, local deliverywill permit these drugs to have much less systemic impact. Further, itmay be ideal to configure the composition of the drug or delivery systemsuch that it maintains a loose affinity to the mucous permitting it todistribute evenly in the flow. Also, in some applications, rather than adrug, a solute such as a salt or other mucous soluble material may bepositioned at a location whereby mucous will contact the substance and aquantity of the substance will become dissolved in the mucous therebychanging some property (e.g., pH, osmolarity, etc) of the mucous. Insome cases, this technique may be used to render the mucous hyperosmolarso that the flowing mucous will draw water and/or other fluid frompolyps, edematous mucosal tissue, etc., thereby providing a drying ordesiccating therapeutic effect.

Additionally or alternatively to substances directed towards localdelivery to affect changes within the sinus cavity, the nasal cavitiesprovide unique access to the olfactory system and thus the brain. Any ofthe devices and methods described herein may also be used to deliversubstances to the brain or alter the functioning of the olfactorysystem. Such examples include, the delivery of energy or the depositionof devices and/or substances and/or substance delivering implant(s) toocclude or alter olfactory perception, to suppress appetite or otherwisetreat obesity, epilepsy (e.g., barbiturates such as phenobarbital ormephoobarbital; iminostilbenes such as carbamazepine and oxcarbazepine;succinimides such as ethylsuximide; valproic acid; benzodiazepines suchas clonazepam, clorazepate, diazepam and lorazepam, gabapentin,lamotrigine, acetazolamide, felbamate, levetiraceam, tiagabine,topiramate, zonisamide, etc.), personality or mental disorders (e.g.,antidepressants, antianxiety agents, antipsychotics, etc.), chronicpain, Parkinson's disease (e.g., dopamine receptor agonists such asbromocriptine, pergolide, ropinitrol and pramipexole; dopamineprecursors such as levodopa; COMT inhibitors such as tolcapone andentacapone; selegiline; muscarinic receptor antagonists such astrihexyphenidyl, benztropine and diphenhydramine) and Alzheimer'sdisease, Huntington's disease or other dementias, disorders of cognitionor chronic degenerative diseases (e.g. tacrine, donepezil, rivastigmine,galantamine, fluoxetine, carbamazepine, clozapine, clonazepam andproteins or genetic therapies that inhibit the formation of beta-amyloidplaques), etc.

The working element need not necessarily be a substance deliveryreservoir 3322. For example, another type of working element useable inthis invention is a laser device. In one embodiment, the laser devicemay comprise an optical fiber that delivers laser energy through thedistal region of the optical fiber. Typical examples of lasers that canbe used in the present invention are Nd:YAG lasers, Ho:NAG lasers, shortpulsed laser systems such as excimer lasers (wavelength: 308 nm, pulselength full width at half maximum height: 60 ns), dye lasers(wavelength: 504 nm, pulse length full width at half maximum height:1200 ns), tunable die lasers, KTP lasers, argon lasers, Alexandritelasers (wavelength: 755 nm, pulse length full width at half maximumheight: 300-500 ns) etc. Such a laser device may also be used inconjunction with or as a part of any method, system or device disclosedin this patent application for laser-assisted ablation or cutting,laser-assisted cauterization or other laser-assisted methods of treatingsinusitis, mucocysts, tumors, polyps, occlusions, obstructions, edema orother conditions of the paranasal sinuses, Eustachian tubes, Lachrymalducts, salivary glands and other hard or soft ear, nose, throat or mouthstructures.

Such devices, systems and methods may also be used for performing otherdiagnostic or therapeutic procedures of Eustachian tubes, tympanums andmiddle ear structures. Examples of such procedures are biopsies,microendoscopy of the Eustachian tube and the middle ear structures,diagnosis and/or treatment of roundwindow ruptures, auditory-ossicledislocations after tympanoplasty, prothesis dislocation afterstapeclotomy, neuroradiologically undetectable liquorrhea caused byotobasal fractures, progressive disorders of the sound-conductingapparatus, Dysplasia of the ear, chronic otitis media mesotympanalis,cholesteatoma, presurgical evaluation of pathologic findings of both themucosal lining and the ossicular chain, epitympanic retraction pocketsof the ear drum, all chronic and recurrent ventilation or drainagedisorders of Eustachian tubes etc.

FIG. 35 shows a perspective view of an embodiment of a guidewirecomprising a sensor used for surgical navigation. Guidewire 3400comprises a sensor 3402 located on the distal region of guidewire 3400.Sensor 3402 enables guidewire 3400 to be used in conjunction with asuitable surgical navigation system. In one embodiment, sensor 3402 isan electromagnetic sensor used in conjunction with an electromagneticsurgical navigation system such as GE InstaTrak™ 3500 plus system. Inone embodiment, guidewire 3400 comprises an anchoring balloon 3404located on the distal region of guidewire 3400. Anchoring balloon 3404is inflated after positioning guidewire 3400 at a target location.Anchoring balloon 3404 anchors guidewire 3400 to adjacent anatomy andprevents accidental repositioning of guidewire 3400 during a diagnosticor therapeutic procedure. Anchoring balloon 3404 may be made fromsuitable compliant or semi-compliant material such as crosslinkedpolyethylene or other polyolefins, polyurethane, flexiblepolyvinylchloride, Nylon etc. In one embodiment, guidewire 3400comprises a soft distal tip. In another embodiment, guidewire 3400comprises a curved distal end e.g. a “J” shaped distal end. Sensorssimilar to sensor 3402 may be present on other diagnostic or therapeuticdevices disclosed herein such as balloon catheters etc. Similarly, thedevices disclosed herein may comprise other types of sensors ortransmitters such as electromagnetic, RF, piezoelectric, magnetic etc.The sensors or transmitters may be in the form of a variety ofconfigurations including but not limited to single coils, multiplecoils, antennae etc. The sensors or transmitters may be oriented in avariety of configurations including but not limited to nested, paired,orthogonal to each other, etc.

FIG. 35A shows an enlarged view of an embodiment of a low profileproximal region of the guidewire in FIG. 35. The proximal region ofguidewire 3400 comprises a distal electrical contact 3406 and a proximalelectrical contact 3408. Distal electrical contact 3406 and proximalelectrical contact 3408 are connected to sensor 3402 by conducting wiresthat run along guidewire 3400 to provide electrical energy to sensor3402. Distal electrical contact 3406 and proximal electrical contact3408 are connected to an external electrical supply by detachableelectrodes. Distal electrical contact 3406 and proximal electricalcontact 3408 can be made of suitable conducting materials such asstainless steel, silver-palladium alloys, silver-platinum alloys etc.Distal electrical contact 3406 and proximal electrical contact 3408 areseparated from each other by a first insulating element 3410. In oneembodiment, guidewire 3400 further comprises a second insulating element3412 located on the proximal end of guidewire 3400. A low profileproximal region allows for the introduction of diagnostic or therapeuticdevices over guidewire 3400.

FIG. 35B shows a perspective view of a method of advancing a diagnosticor therapeutic device over the guidewire in FIG. 35. In this example,the diagnostic or therapeutic device is a balloon catheter 3414comprising a shaft 3416 having a balloon 3418 at the distal region ofshaft 3416 and a hub 3420 at the proximal end of shaft 3416. Ballooncatheter is advanced into a target anatomical region over the guidewire3400. In this example, guidewire 3400 comprises a low profile proximalend so that devices can be introduced in an over-the-wire manner into atarget anatomy.

FIG. 35C shows a perspective view of an embodiment of a combination of aguidewire comprising a sensor having a diagnostic or therapeutic devicepreloaded on the guidewire. In this example, the diagnostic ortherapeutic device is balloon catheter 3414. The proximal end ofguidewire 3400 is connected to an external electrical supply 3422 byconducting wires 3424. In this example, guidewire 3400 does not have alow profile proximal end so that devices cannot be introduced in anover-the-wire manner into a target anatomy. Thus, balloon catheter 3414is preloaded on guidewire 3400 by inserting proximal end of ballooncatheter 3414 over distal end of guidewire 3400.

FIG. 35D shows a perspective view of a second embodiment of acombination of a guidewire comprising a sensor having a diagnostic ortherapeutic device preloaded on the guidewire. In this example, thediagnostic or therapeutic device is balloon catheter 3414. The proximalend of guidewire 3400 is connected by conducting wires 3426 to plug3428. Plug 3428 detachably fits into an external power supply 3430. Inthis example, guidewire 3400 does not have a low profile proximal end sothat devices cannot be introduced in an over-the-wire manner into atarget anatomy. Thus, balloon catheter 3414 is preloaded on guidewire3400 by inserting proximal end of balloon catheter 3414 over distal endof guidewire 3400.

One or more flexible regions especially flexible distal regions on thediagnostic or therapeutic devices disclosed herein may comprise bendingor deflecting elements. Examples of such bending or deflecting elementsare one or more pull wires etc. made of suitable materials such asstainless steel flat wire etc.

The abovementioned devices and methods may also be used for diagnosingor treating other conditions caused by narrowing or blockage ofstructures in the ear, nose, throat or mouth such as choanal atresia.

Various devices described herein such as catheters may comprise one ormore lumens such as end-to-end lumens, zipper lumens, rapid exchangelumens, parallel lumen surrounded by a jacket etc.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. All reasonableadditions, deletions, modifications and alterations are to be consideredequivalents of the described examples and embodiments and are to beincluded within the scope of the following claims.

1. A device for insertion into a paranasal sinus, Eustachian tube,naso-lacrimal duct or other anatomical structure of the ear, nose orthroat and for guiding a second device to that paranasal sinus,Eustachian tube, naso-lacrimal duct or other anatomical structure, saiddevice comprising: an elongate shaft having a proximal end and a distalend, at least a portion of said shaft being formed of plasticallydeformable material such that it may be bent into a desired shape; abulbous tip member on the distal end of the shaft; and a handleremovably attachable to the proximal end of the shaft.
 2. A systemcomprising a) device according to claim 1 in combination with b) asecond device that is advanceable over said shaft when the handle isdetached from the proximal end of the shaft.
 3. A system according toclaim 2 wherein the second device comprises a catheter.
 4. A systemaccording to claim 3 wherein the catheter comprises a balloon catheter.